Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Medtronic CoreValve Evolut R U.S. Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207569
Recruitment Status : Active, not recruiting
First Posted : August 4, 2014
Results First Posted : December 12, 2017
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aortic Stenosis
Intervention Device: CoreValve Evolut R TAVR system
Enrollment 241
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Period Title: Enrolled to Implant
Started 241 [1]
Completed 237 [2]
Not Completed 4
[1]
241 entered procedure room for implant
[2]
237 actual implants
Period Title: Implant to 30 Days
Started 237
Completed 233
Not Completed 4
Period Title: 30 Days to 6 Months
Started 233
Completed 222
Not Completed 11
Period Title: 6 Months - 1 Year
Started 222
Completed 213
Not Completed 9
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components: >

  1. Evolut R Transcatheter Aortic Valve (TAV) >
  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath >
  3. EnVeo R Loading System (LS) > > CoreValve Evolut R TAVR system
Overall Number of Baseline Participants 241
Hide Baseline Analysis Population Description
241 attempted implant 237 implanted
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 241 participants
84.4  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 241 participants
Female
165
  68.5%
Male
76
  31.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 241 participants
241
1.Primary Outcome
Title All-cause Mortality at 30 Days by Percent
Hide Description Percentage of patients that died by any cause at 30 days
Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of partcipants
2.5
(1.1 to 5.5)
2.Primary Outcome
Title Percentage of Patients With Disabling Stroke at 30 Days
Hide Description

Stroke Diagnostic Criteria:

>

Acute episode of focal or global neurological deficit with at least 2 of the following:

  • change in level of consciousness >
  • hemiplegia, hemiparesis
  • numbness or sensory loss affecting 1 side >
  • dysphasia or aphasia
  • hemianopia
  • amaurosis fugax >
  • other neurological signs or symptoms consistent with stroke

    2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist

    3.) Confirmation of the diagnosis by at least 1 of the following:

  • Neurological specialist >
  • Neuroimaging procedure, or on clincial grounds alone > Stroke: durations of neural deficit > 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death

Defined by VARC II:

> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline

Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.3
(1.7 to 6.6)
3.Primary Outcome
Title Percent Device Success Rate Between 24 and 7 Day
Hide Description

Percentage of patients with Device Success defined as:

  • Absence of procedural mortality, AND
  • Correct positioning of a single Evolut R valve into the proper anatomical location, AND
  • Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity < 3m/sec, AND
  • Absence of moderate or severe prosthetic valve regurgitation
Time Frame Assessed at 24 hours to seven days post implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 237
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of overall device success
69.2
(62.3 to 75.5)
4.Primary Outcome
Title Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)
Hide Description Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.
Time Frame Assessed at 24 hours to 7 days post implantation
Hide Outcome Measure Data
Hide Analysis Population Description
Subset includes all subjects who are implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 237
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of partcipants
96.5
(93.3 to 98.5)
5.Secondary Outcome
Title Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)
Hide Description Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.
Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
The safety subset includes all subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, or any monitoring line placed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of overall patients
0.0
(0.0 to 1.6)
6.Secondary Outcome
Title Coronary Artery Obstruction Requiring Intervention.
Hide Description Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.
Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.4
(0.1 to 3.0)
7.Secondary Outcome
Title Percent VARC II Combined Safety Endpoint at 30 Days
Hide Description

VARC II composite safety endpoint rate includes percent freedom from the following components:

  • All-cause mortality
  • All stroke (disabling and non-disabling)
  • Life-threatening bleeding
  • Acute kidney injury: stage 2 or 3 (including renal replacement therapy).
  • Coronary artery obstruction requiring intervention.
  • Major vascular complication.
  • Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.5
(10.6 to 19.7)
8.Secondary Outcome
Title Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).
Hide Description

Stage 2

  1. Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR

    >

  2. Urine output <0.5 mL/kg/h for >12 but <24 h > Stage 3 >

1) Increase in serum creatinine to ≥300% (>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR

  • Urine output <0.3 ml/kg/h for ≥24 h OR

    >

  • Anuria for ≥12 h
Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.3
(0.4 to 3.9)
9.Secondary Outcome
Title Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate
Hide Description
  1. Fatal bleeding (BARC type 5) OR

    >

  2. Bleeding in a critical organs, such as intracranial, intraspinal,

    > intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR

    >

  3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR

    >

  4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* > (BARC type 3b)
Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.1
(4.4 to 11.2)
10.Secondary Outcome
Title Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days
Hide Description Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure
Time Frame Assessed at 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed. Additionally, these patients did NOT have ICD or PPM at the time of the index procedure.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 201
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.7
(14.7 to 26.0)
11.Secondary Outcome
Title Percent Resheath and Recapture Success Rate
Hide Description Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.
Time Frame Assessed intra-procedurally
Hide Outcome Measure Data
Hide Analysis Population Description
65 patients had resheath or recapture feature used during the 241 attempted procedures.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 65
Measure Type: Number
Unit of Measure: percentage of resheath or recapture
96.9
12.Secondary Outcome
Title Hemodynamic Performance -Mean Gradient
Hide Description Mean gradient by Doppler echocardiography.
Time Frame Assessed at baseline, 30 days, 6 months, and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system. Only subjects with echo can be analyzed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 237
Mean (Standard Deviation)
Unit of Measure: mmHg
baseline Number Analyzed 237 participants
48.2  (10)
30 days Number Analyzed 229 participants
7.8  (3.1)
6 months Number Analyzed 208 participants
8.4  (3.8)
1 year Number Analyzed 188 participants
9.0  (4.8)
13.Secondary Outcome
Title Major Vascular Complication
Hide Description
  1. Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR

    >

  2. Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR

    >

  3. Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR

    >

  4. The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR

    >

  5. Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR

    >

  6. Surgery for access site nerve injury OR

    >

  7. Permanent access related nerve injury
Time Frame Assessed at 30 days post-implantation
Hide Outcome Measure Data
Hide Analysis Population Description
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.5
(4.8 to 11.7)
14.Secondary Outcome
Title Hemodynamic Performance - Aortic Valve Area
Hide Description Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2
Time Frame Assessed at baseline, 30 days, 6 months, and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation - only subjects with echo can be analyzed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 237
Mean (Standard Deviation)
Unit of Measure: cm²
baseline Number Analyzed 237 participants
0.6  (0.2)
30 days Number Analyzed 229 participants
1.9  (0.5)
6 months Number Analyzed 208 participants
1.8  (0.5)
1 year Number Analyzed 188 participants
1.8  (0.5)
15.Secondary Outcome
Title Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe
Hide Description Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.
Time Frame Assessed at 30 days, 6 months, and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation. Only subjects with echo can be analyzed.
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description:

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

  1. Evolut R Transcatheter Aortic Valve (TAV)

    >

  2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath

    >

  3. EnVeo R Loading System (LS)

    >

    > CoreValve Evolut R TAVR system

Overall Number of Participants Analyzed 237
Measure Type: Number
Unit of Measure: percentage of participants
30 days Number Analyzed 229 participants
5.7
6 months Number Analyzed 208 participants
5.4
1 year Number Analyzed 237 participants
3.7
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CoreValve Evolut R TAVR System
Hide Arm/Group Description

The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:

Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)

All-Cause Mortality
CoreValve Evolut R TAVR System
Affected / at Risk (%)
Total   20/241 (8.30%)    
Hide Serious Adverse Events
CoreValve Evolut R TAVR System
Affected / at Risk (%) # Events
Total   170/241 (70.54%)    
Blood and lymphatic system disorders   
Anaemia  1  36/241 (14.94%)  39
Haemolytic Anaemia  1  1/241 (0.41%)  1
Iron Deficiency Anaemia  1  1/241 (0.41%)  1
Splenic Infarction  1  1/241 (0.41%)  1
Thrombocytopenia  1  2/241 (0.83%)  2
Cardiac disorders   
Acute Myocardial Infarction  1  3/241 (1.24%)  3
Angina Unstable  1  1/241 (0.41%)  1
Aortic Valve Incompetence  1  1/241 (0.41%)  1
Atrial Fibrillation  1  15/241 (6.22%)  16
Atrioventricular Block Complete  1  32/241 (13.28%)  32
Atrioventricular Block Second Degree  1  3/241 (1.24%)  3
Bradycardia  1  2/241 (0.83%)  2
Bundle Branch Block Left  1  4/241 (1.66%)  4
Bundle Branch Block Right  1  1/241 (0.41%)  1
Cardiac Arrest  1  4/241 (1.66%)  4
Cardiac Failure  1  6/241 (2.49%)  6
Cardiac Failure Acute  1  1/241 (0.41%)  1
Cardiac Failure Congestive  1  22/241 (9.13%)  28
Cardiac Perforation  1  3/241 (1.24%)  3
Cardiogenic Shock  1  2/241 (0.83%)  2
Coronary Artery Disease  1  1/241 (0.41%)  1
Intracardiac Thrombus  1  1/241 (0.41%)  1
Left Ventricular Dysfunction  1  1/241 (0.41%)  1
Mitral Valve Incompetence  1  4/241 (1.66%)  4
Myocardial Infarction  1  1/241 (0.41%)  1
Myocardial Ischaemia  1  1/241 (0.41%)  1
Nodal Rhythm  1  1/241 (0.41%)  1
Pericardial Effusion  1  3/241 (1.24%)  3
Pulseless Electrical Activity  1  1/241 (0.41%)  1
Right Ventricular Dysfunction  1  1/241 (0.41%)  1
Right Ventricular Failure  1  1/241 (0.41%)  1
Sinus Bradycardia  1  3/241 (1.24%)  3
Sinus Node Dysfunction  1  2/241 (0.83%)  2
Stress Cardiomyopathy  1  1/241 (0.41%)  1
Ventricular Asystole  1  1/241 (0.41%)  1
Ventricular Fibrillation  1  1/241 (0.41%)  1
Ventricular Tachycardia  1  2/241 (0.83%)  2
Eye disorders   
Cataract  1  2/241 (0.83%)  2
Glaucoma  1  1/241 (0.41%)  1
Visual Impairment  1  1/241 (0.41%)  1
Gastrointestinal disorders   
Dysphagia  1  1/241 (0.41%)  1
Gastric Ulcer  1  2/241 (0.83%)  2
Gastrointestinal Haemorrhage  1  12/241 (4.98%)  12
Gastrooesophageal Reflux Disease  1  1/241 (0.41%)  1
Hiatus Hernia  1  1/241 (0.41%)  1
Inguinal Hernia  1  4/241 (1.66%)  4
Intestinal Ischaemia  1  1/241 (0.41%)  1
Intestinal Obstruction  1  1/241 (0.41%)  1
Retroperitoneal Haemorrhage  1  4/241 (1.66%)  5
General disorders   
Chest Pain  1  3/241 (1.24%)  3
Death  1  2/241 (0.83%)  2
Device Deployment Issue  1  1/241 (0.41%)  1
Device Dislocation  1  1/241 (0.41%)  1
Implant Site Haemorrhage  1  3/241 (1.24%)  4
Implant Site Pain  1  1/241 (0.41%)  1
Lead Dislodgement  1  1/241 (0.41%)  1
Oedema Peripheral  1  1/241 (0.41%)  1
Systemic Inflammatory Response Syndrome  1  1/241 (0.41%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/241 (0.41%)  1
Cholecystitis Acute  1  1/241 (0.41%)  1
Gallbladder Disorder  1  1/241 (0.41%)  1
Infections and infestations   
Abdominal Wall Abscess  1  1/241 (0.41%)  1
Acquired Immunodeficiency Syndrome  1  1/241 (0.41%)  1
Bronchitis  1  1/241 (0.41%)  1
Cellulitis  1  1/241 (0.41%)  1
Clostridium Difficile Colitis  1  5/241 (2.07%)  5
Diverticulitis  1  1/241 (0.41%)  1
Diverticulitis Intestinal Haemorrhagic  1  1/241 (0.41%)  1
Gangrene  1  1/241 (0.41%)  1
Incision Site Infection  1  2/241 (0.83%)  2
Influenza  1  1/241 (0.41%)  1
Osteomyelitis  1  1/241 (0.41%)  1
Pneumonia  1  12/241 (4.98%)  16
Pneumonia Staphylococcal  1  1/241 (0.41%)  1
Postoperative Wound Infection  1  1/241 (0.41%)  1
Sepsis  1  8/241 (3.32%)  8
Septic Shock  1  1/241 (0.41%)  1
Upper Respiratory Tract Infection  1  2/241 (0.83%)  2
Urinary Tract Infection  1  9/241 (3.73%)  9
Urosepsis  1  1/241 (0.41%)  2
Injury, poisoning and procedural complications   
Ankle Fracture  1  1/241 (0.41%)  1
Arterial Injury  1  2/241 (0.83%)  2
Compression Fracture  1  1/241 (0.41%)  1
Feeding Tube Complication  1  1/241 (0.41%)  1
Femur Fracture  1  1/241 (0.41%)  1
Hip Fracture  1  3/241 (1.24%)  3
Incision Site Complication  1  4/241 (1.66%)  4
Incision Site Haematoma  1  6/241 (2.49%)  7
Incision Site Haemorrhage  1  1/241 (0.41%)  1
Laceration  1  1/241 (0.41%)  1
Pelvic Fracture  1  2/241 (0.83%)  2
Seroma  1  1/241 (0.41%)  1
Subdural Haematoma  1  1/241 (0.41%)  1
Vascular Pseudoaneurysm  1  2/241 (0.83%)  2
Investigations   
Blood Magnesium Decreased  1  2/241 (0.83%)  2
Blood Pressure Increased  1  1/241 (0.41%)  1
International Normalised Ratio Increased  1  2/241 (0.83%)  2
Urine Output Decreased  1  1/241 (0.41%)  1
Metabolism and nutrition disorders   
Fluid Overload  1  2/241 (0.83%)  2
Gout  1  1/241 (0.41%)  1
Hyperglycaemia  1  1/241 (0.41%)  1
Hypoalbuminaemia  1  1/241 (0.41%)  1
Hypoglycaemia  1  2/241 (0.83%)  2
Hypokalaemia  1  3/241 (1.24%)  3
Hypomagnesaemia  1  1/241 (0.41%)  1
Hyponatraemia  1  1/241 (0.41%)  1
Hypovolaemia  1  1/241 (0.41%)  1
Lactic Acidosis  1  1/241 (0.41%)  1
Metabolic Acidosis  1  1/241 (0.41%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/241 (0.41%)  1
Arthritis  1  1/241 (0.41%)  1
Muscular Weakness  1  1/241 (0.41%)  1
Osteoarthritis  1  1/241 (0.41%)  1
Rotator Cuff Syndrome  1  1/241 (0.41%)  1
Spinal Column Stenosis  1  1/241 (0.41%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma  1  1/241 (0.41%)  1
Bladder Cancer  1  1/241 (0.41%)  1
Breast Cancer  1  1/241 (0.41%)  1
Chondrosarcoma  1  1/241 (0.41%)  1
Colon Cancer  1  1/241 (0.41%)  1
Colon Neoplasm  1  1/241 (0.41%)  1
Small Intestine Adenocarcinoma  1  1/241 (0.41%)  1
Squamous Cell Carcinoma  1  2/241 (0.83%)  2
Nervous system disorders   
Brain Injury  1  1/241 (0.41%)  1
Carotid Artery Stenosis  1  1/241 (0.41%)  1
Cerebral Haemorrhage  1  1/241 (0.41%)  1
Cerebral Infarction  1  1/241 (0.41%)  1
Cerebrovascular Accident  1  10/241 (4.15%)  12
Dizziness  1  1/241 (0.41%)  1
Encephalopathy  1  2/241 (0.83%)  2
Hemiplegia  1  1/241 (0.41%)  1
Hypoxic-Ischaemic Encephalopathy  1  1/241 (0.41%)  1
Ischaemic Stroke  1  3/241 (1.24%)  3
Metabolic Encephalopathy  1  1/241 (0.41%)  1
Partial Seizures  1  1/241 (0.41%)  1
Speech Disorder  1  1/241 (0.41%)  1
Syncope  1  2/241 (0.83%)  2
Thalamic Infarction  1  1/241 (0.41%)  1
Transient Ischaemic Attack  1  4/241 (1.66%)  5
Psychiatric disorders   
Delirium  1  1/241 (0.41%)  1
Hallucination, Visual  1  1/241 (0.41%)  1
Mental Disorder  1  4/241 (1.66%)  4
Renal and urinary disorders   
Acute Kidney Injury  1  5/241 (2.07%)  6
Haematuria  1  1/241 (0.41%)  1
Nephrolithiasis  1  1/241 (0.41%)  1
Renal Failure  1  1/241 (0.41%)  1
Renal Infarct  1  1/241 (0.41%)  1
Urinary Retention  1  2/241 (0.83%)  3
Reproductive system and breast disorders   
Benign Prostatic Hyperplasia  1  1/241 (0.41%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Pulmonary Oedema  1  1/241 (0.41%)  1
Acute Respiratory Failure  1  1/241 (0.41%)  1
Chronic Obstructive Pulmonary Disease  1  8/241 (3.32%)  11
Dyspnoea  1  2/241 (0.83%)  2
Epistaxis  1  1/241 (0.41%)  1
Haemoptysis  1  2/241 (0.83%)  2
Pleural Effusion  1  4/241 (1.66%)  6
Pneumonia Aspiration  1  1/241 (0.41%)  2
Pulmonary Hypertension  1  2/241 (0.83%)  2
Pulmonary Oedema  1  5/241 (2.07%)  5
Respiratory Depression  1  1/241 (0.41%)  1
Respiratory Failure  1  13/241 (5.39%)  14
Stridor  1  1/241 (0.41%)  1
Skin and subcutaneous tissue disorders   
Diabetic Ulcer  1  1/241 (0.41%)  1
Skin Ulcer  1  1/241 (0.41%)  1
Subacute Cutaneous Lupus Erythematosus  1  1/241 (0.41%)  1
Surgical and medical procedures   
Hospitalisation  1  1/241 (0.41%)  18
Vascular disorders   
Aortic Dissection  1  1/241 (0.41%)  1
Aortic Dissection Rupture  1  1/241 (0.41%)  1
Arteriosclerosis  1  1/241 (0.41%)  1
Deep Vein Thrombosis  1  2/241 (0.83%)  2
Femoral Artery Dissection  1  2/241 (0.83%)  2
Femoral Artery Occlusion  1  1/241 (0.41%)  1
Haematoma  1  1/241 (0.41%)  1
Haemorrhage  1  1/241 (0.41%)  2
Hypertension  1  9/241 (3.73%)  9
Hypotension  1  16/241 (6.64%)  16
Iliac Vein Occlusion  1  1/241 (0.41%)  1
Intermittent Claudication  1  1/241 (0.41%)  1
Labile Blood Pressure  1  3/241 (1.24%)  3
Labile Hypertension  1  1/241 (0.41%)  1
Malignant Hypertension  1  1/241 (0.41%)  1
Orthostatic Hypotension  1  1/241 (0.41%)  1
Peripheral Arterial Occlusive Disease  1  2/241 (0.83%)  2
Peripheral Artery Dissection  1  1/241 (0.41%)  1
Peripheral Artery Stenosis  1  2/241 (0.83%)  2
Peripheral Ischaemia  1  3/241 (1.24%)  3
Peripheral Vascular Disorder  1  2/241 (0.83%)  2
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CoreValve Evolut R TAVR System
Affected / at Risk (%) # Events
Total   197/241 (81.74%)    
Blood and lymphatic system disorders   
Anaemia  1  48/241 (19.92%)  49
Leukocytosis  1  19/241 (7.88%)  19
Thrombocytopenia  1  37/241 (15.35%)  37
Cardiac disorders   
Atrial Fibrillation  1  19/241 (7.88%)  21
Atrioventricular Block First Degree  1  39/241 (16.18%)  40
Bundle Branch Block Left  1  79/241 (32.78%)  82
Bundle Branch Block Right  1  13/241 (5.39%)  13
Cardiac Failure Congestive  1  16/241 (6.64%)  17
Ventricular Extrasystoles  1  13/241 (5.39%)  13
General disorders   
Chest Pain  1  13/241 (5.39%)  14
Infections and infestations   
Urinary Tract Infection  1  32/241 (13.28%)  38
Injury, poisoning and procedural complications   
Fall  1  18/241 (7.47%)  25
Incision Site Haematoma  1  16/241 (6.64%)  18
Metabolism and nutrition disorders   
Hypokalaemia  1  20/241 (8.30%)  20
Hyponatraemia  1  14/241 (5.81%)  16
Renal and urinary disorders   
Acute Kidney Injury  1  17/241 (7.05%)  17
Renal Failure  1  13/241 (5.39%)  13
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  14/241 (5.81%)  14
Pleural Effusion  1  27/241 (11.20%)  29
Vascular disorders   
Hypertension  1  40/241 (16.60%)  44
Hypotension  1  20/241 (8.30%)  21
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sara Saul
Organization: Medtronic
Phone: 763-526-1965
EMail: sara.m.saul@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT02207569    
Other Study ID Numbers: 10126779DOC
First Submitted: July 24, 2014
First Posted: August 4, 2014
Results First Submitted: September 30, 2016
Results First Posted: December 12, 2017
Last Update Posted: March 3, 2020