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Trial record 1 of 1 for:    NCT01314313
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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A (PARTNERII A)

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: NCT01314313
Recruitment Status : Active, not recruiting
First Posted : March 14, 2011
Results First Posted : August 14, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Symptomatic Severe Aortic Stenosis
Interventions Device: TAVR Implantation with SAPIEN XT
Device: SAVR Implantation
Enrollment 2032
Recruitment Details Between December 23, 2011 to November 6, 2013 2,032 patients were enrolled into the PARTNER II A SAPIEN XT vs SAVR Intermediate Risk Trial at 57 sites in the United States and Canada.
Pre-assignment Details  
Arm/Group Title PIIA: SAPIEN XT Control: SAVR
Hide Arm/Group Description

Edwards SAPIEN XT Transcatheter Heart Valve (THV)

NOTE: SAVR with surgical bioprosthetic heart valve is the control arm.

Surgical Aortic Valve Replacement (SAVR)
Period Title: Overall Study
Started 1011 1021
As Treated 994 944
Valve Implanted 974 936
Completed [1] 784 710
Not Completed 227 311
[1]
This is two year follow-up
Arm/Group Title PIIA: SAPIEN XT Control: SAVR Total
Hide Arm/Group Description Edwards SAPIEN XT Transcatheter Heart Valve (THV) Surgical Aortic Valve Replacement (SAVR); Control for PIIA: SAPIEN XT Total of all reporting groups
Overall Number of Baseline Participants 1011 1021 2032
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1011 participants 1021 participants 2032 participants
81.5  (6.70) 81.7  (6.71) 81.6  (6.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1011 participants 1021 participants 2032 participants
Female
463
  45.8%
461
  45.2%
924
  45.5%
Male
548
  54.2%
560
  54.8%
1108
  54.5%
STS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  % risk of mortality or morbidity
Number Analyzed 1011 participants 1021 participants 2032 participants
5.8  (2.08) 5.8  (1.87) 5.8  (1.98)
[1]
Measure Description: The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.
NYHA Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1011 participants 1021 participants 2032 participants
NYHA I/II 229 244 473
NYHA III/VI 782 776 1558
[1]
Measure Description: New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
1.Primary Outcome
Title All-cause Death or Disabling Stroke to Two Years
Hide Description All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants include all patients who were randomized.
Arm/Group Title PIIA: SAPIEN XT Control: SAVR
Hide Arm/Group Description:
Edwards SAPIEN XT Transcatheter Heart Valve (THV)
Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed 1011 1021
Measure Type: Count of Participants
Unit of Measure: Participants
192
  19.0%
202
  19.8%
2.Secondary Outcome
Title Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
Hide Description The number of days the patients are alive and out of the hospital.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population: All randomized patients with the exception of Total Aortic Regurgitation and Effective Orifice Area which was analyzed with the Valve Implant Population: All randomized patients receiving the valve.
Arm/Group Title PIIA: SAPIEN XT Control: SAVR
Hide Arm/Group Description:
Edwards SAPIEN XT Transcatheter Heart Valve (THV)
Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed 998 953
Mean (Standard Deviation)
Unit of Measure: days
629.4  (208.54) 597.8  (236.80)
3.Secondary Outcome
Title Total Aortic Regurgitation (AR) at 2 Years
Hide Description Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received the valve were analyzed. Note: Echos were not available for all the patients who made the follow-up visit.
Arm/Group Title PIIA: SAPIEN XT Control: SAVR
Hide Arm/Group Description:
Edwards SAPIEN XT Transcatheter Heart Valve (THV)
Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed 606 520
Mean (Standard Deviation)
Unit of Measure: Grade
1.2  (1.0) 0.5  (0.7)
4.Secondary Outcome
Title 6MWT Change From Baseline
Hide Description Six Minute Walk Test change from baseline to 2 years
Time Frame Baseline and 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PIIA: SAPIEN XT Control: SAVR
Hide Arm/Group Description:
Edwards SAPIEN XT Transcatheter Heart Valve (THV)
Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed 604 1021
Mean (Standard Deviation)
Unit of Measure: meters
14.5  (128.7) NA [1]   (NA)
[1]
This secondary endpoint analyzes change within the SAPIEN XT Cohort.
5.Secondary Outcome
Title NYHA Classification at 2 Years
Hide Description New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PIIA: SAPIEN XT Control: SAVR
Hide Arm/Group Description:
Intermediate Risk Surgical Patients: Transcatheter Heart Valve (THV)
Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed 737 649
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5  (0.7) 1.4  (0.6)
6.Secondary Outcome
Title Effective Orifice Area (EOA)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Effective Orifice Area is listed for only the patients who had echo available at the follow-up visit.
Arm/Group Title PIIA: SAPIEN XT Control: SAVR
Hide Arm/Group Description:
Edwards SAPIEN XT Transcatheter Heart Valve (THV)
Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed 573 490
Mean (Standard Deviation)
Unit of Measure: cm^2
1.5  (0.4) 1.4  (0.4)
Time Frame Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock.
Adverse Event Reporting Description Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
 
Arm/Group Title PIIA: SAPIEN XT - 2 Year Control: SAVR - 2 Year
Hide Arm/Group Description Edwards SAPIEN XT Transcatheter Heart Valve (THV)

Surgical Aortic Valve Replacement (SAVR)

NOTE: SAVR with surgical bioprosthetic heart valve is the control arm.

All-Cause Mortality
PIIA: SAPIEN XT - 2 Year Control: SAVR - 2 Year
Affected / at Risk (%) Affected / at Risk (%)
Total   166/1011 (16.42%)      170/1021 (16.65%)    
Hide Serious Adverse Events
PIIA: SAPIEN XT - 2 Year Control: SAVR - 2 Year
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   666/974 (68.38%)      672/936 (71.79%)    
Blood and lymphatic system disorders     
Anemia/Hemolytic anemia  1  24/974 (2.46%)  26 38/936 (4.06%)  43
Thrombocytopenia  1  8/974 (0.82%)  8 24/936 (2.56%)  24
Cardiac disorders     
Angina/Cardiac chest pain  1  22/974 (2.26%)  28 24/936 (2.56%)  30
Arrhythmia/Conduction system injury (defect)  1  170/974 (17.45%)  186 196/936 (20.94%)  226
Cardiac arrest  1  33/974 (3.39%)  33 36/936 (3.85%)  38
Cardiac tamponade/Pericardial effusion  1  21/974 (2.16%)  21 13/936 (1.39%)  13
Cardiogenic shock  1  9/974 (0.92%)  9 20/936 (2.14%)  20
Heart failure/CHF/Low output failure  1  127/974 (13.04%)  197 103/936 (11.00%)  134
MI  1  29/974 (2.98%)  29 26/936 (2.78%)  30
Mitral valve injury or insufficiency  1  1/974 (0.10%)  1 2/936 (0.21%)  2
Pericarditis  1  0/974 (0.00%)  0 2/936 (0.21%)  2
Gastrointestinal disorders     
Gastro Intestinal event - Non-hemorrhagic  1  67/974 (6.88%)  77 53/936 (5.66%)  65
General disorders     
Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction  1  24/974 (2.46%)  30 8/936 (0.85%)  9
Aortic insufficiency/Regurgitation PV leak - Structural dysfunction  1  7/974 (0.72%)  7 1/936 (0.11%)  1
Aortic insufficiency/Regurgitation non valvular cause  1  2/974 (0.21%)  3 0/936 (0.00%)  0
Coronary flow obstruction/Transvalvular flow disturbance  1  6/974 (0.62%)  9 8/936 (0.85%)  8
Device embolization  1  6/974 (0.62%)  6 0/936 (0.00%)  0
Device migration/malposition requiring intervention  1  6/974 (0.62%)  6 0/936 (0.00%)  0
Edema  1  7/974 (0.72%)  7 7/936 (0.75%)  7
Exercise intolerance or weakness  1  2/974 (0.21%)  2 2/936 (0.21%)  2
Miscellaneous - Drug reaction  1  2/974 (0.21%)  2 6/936 (0.64%)  6
Miscellaneous - Other  1  22/974 (2.26%)  28 23/936 (2.46%)  24
Miscellaneous - Suicide  1  1/974 (0.10%)  1 0/936 (0.00%)  0
Multi organ failure  1  4/974 (0.41%)  4 10/936 (1.07%)  10
Other  1  70/974 (7.19%)  80 68/936 (7.26%)  72
Unknown cause of death  1  21/974 (2.16%)  21 19/936 (2.03%)  19
Valve stenosis - Restenosis  1  1/974 (0.10%)  1 1/936 (0.11%)  1
Valve thrombosis  1  1/974 (0.10%)  1 0/936 (0.00%)  0
Infections and infestations     
Infection - Access site infection  1  16/974 (1.64%)  17 2/936 (0.21%)  2
Infection - Bacteremia  1  14/974 (1.44%)  15 13/936 (1.39%)  14
Infection - Endocarditis  1  14/974 (1.44%)  15 11/936 (1.18%)  11
Infection - Other  1  37/974 (3.80%)  48 56/936 (5.98%)  67
Infection - Respiratory infection  1  93/974 (9.55%)  110 100/936 (10.68%)  111
Infection - Sepsis  1  41/974 (4.21%)  44 47/936 (5.02%)  52
Infection - Sternal wound infection  1  1/974 (0.10%)  1 14/936 (1.50%)  18
Infection - Urinary tract infection  1  40/974 (4.11%)  47 31/936 (3.31%)  36
Injury, poisoning and procedural complications     
Access site and access related vascular injury - Aortic root rupture  1  2/974 (0.21%)  2 2/936 (0.21%)  2
Access site and access related vascular injury - Dissection  1  20/974 (2.05%)  21 8/936 (0.85%)  8
Access site/access related vascular injury - Distal embolization (noncerebral) from vascular source  1  1/974 (0.10%)  1 0/936 (0.00%)  0
Access site/related vascular injury - Failure of perc access site closure causing intervention  1  3/974 (0.31%)  3 0/936 (0.00%)  0
Access site and access related vascular injury - Hematoma  1  2/974 (0.21%)  3 5/936 (0.53%)  5
Access site and access related vascular injury - Perforation  1  9/974 (0.92%)  9 7/936 (0.75%)  7
Access site and access related vascular injury - Pseudoaneurysm  1  10/974 (1.03%)  10 1/936 (0.11%)  1
Access site and access related vascular injury - Rupture  1  3/974 (0.31%)  3 1/936 (0.11%)  1
Access site and access related vascular injury - Stenosis  1  1/974 (0.10%)  1 0/936 (0.00%)  0
Access site and access related vascular injury - Ventricular rupture (Apical rupture)  1  4/974 (0.41%)  4 1/936 (0.11%)  1
Anesthesia related complication - Aspiration  1  1/974 (0.10%)  1 0/936 (0.00%)  0
Anesthesia related complication - Confusion  1  0/974 (0.00%)  0 1/936 (0.11%)  1
Anesthesia related complication - Dysphasia  1  0/974 (0.00%)  0 1/936 (0.11%)  1
Anesthesia related complication - Other  1  3/974 (0.31%)  3 2/936 (0.21%)  2
Miscellaneous - Fall  1  25/974 (2.57%)  26 32/936 (3.42%)  34
Investigations     
Abnormal lab value  1  24/974 (2.46%)  28 42/936 (4.49%)  46
Musculoskeletal and connective tissue disorders     
Musculoskeletal - Fracture  1  47/974 (4.83%)  51 43/936 (4.59%)  45
Musculoskeletal - Pain  1  33/974 (3.39%)  35 32/936 (3.42%)  35
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Miscellaneous - Cancer  1  27/974 (2.77%)  31 26/936 (2.78%)  28
Nervous system disorders     
Encephalopathy  1  7/974 (0.72%)  7 4/936 (0.43%)  4
Mental state change (not neurological) - Dementia  1  7/974 (0.72%)  8 4/936 (0.43%)  5
Neurological - Change in level of consciousness  1  0/974 (0.00%)  0 6/936 (0.64%)  6
Neurological - Dysphasia/Aphasia  1  5/974 (0.51%)  6 0/936 (0.00%)  0
Neurological - Hemianopia (blindness in one half of the visual field)  1  0/974 (0.00%)  0 2/936 (0.21%)  2
Neurological - Hemiparesis (One sided body weakness)  1  1/974 (0.10%)  1 6/936 (0.64%)  6
Neurological - Hemiplegia (One side limb weakness)  1  0/974 (0.00%)  0 3/936 (0.32%)  3
Neurological - Hemorrhagic stroke  1  15/974 (1.54%)  15 11/936 (1.18%)  12
Neurological - Ischemic stroke  1  57/974 (5.85%)  58 46/936 (4.91%)  47
Neurological - Other  1  18/974 (1.85%)  20 24/936 (2.56%)  25
Neurological - Other new neurological sign consistent with stroke  1  6/974 (0.62%)  6 4/936 (0.43%)  4
Neurological - Syncope  1  2/974 (0.21%)  2 1/936 (0.11%)  1
Neurological - TIA  1  22/974 (2.26%)  23 14/936 (1.50%)  15
Neurological - Undetermined stroke  1  9/974 (0.92%)  9 5/936 (0.53%)  5
Psychiatric disorders     
Delirium  1  2/974 (0.21%)  2 2/936 (0.21%)  2
Mental state change (not neurological) - Confusion  1  14/974 (1.44%)  14 14/936 (1.50%)  16
Mental state change (not neurological) - Depression  1  2/974 (0.21%)  2 1/936 (0.11%)  1
Neurological - Cognitive impairment  1  0/974 (0.00%)  0 3/936 (0.32%)  3
Renal and urinary disorders     
Genito-Urinary event - Non-hemorrhagic  1  18/974 (1.85%)  18 10/936 (1.07%)  10
Renal insufficiency or renal failure  1  48/974 (4.93%)  53 80/936 (8.55%)  88
Respiratory, thoracic and mediastinal disorders     
Respiratory event - Aspiration  1  4/974 (0.41%)  4 7/936 (0.75%)  10
Respiratory event - Atelectasis  1  1/974 (0.10%)  1 1/936 (0.11%)  1
Respiratory event - Dyspnea  1  18/974 (1.85%)  20 21/936 (2.24%)  24
Respiratory event - Other  1  23/974 (2.36%)  25 18/936 (1.92%)  19
Respiratory event - Pneumothorax  1  8/974 (0.82%)  8 16/936 (1.71%)  18
Respiratory event - Pulmonary edema  1  6/974 (0.62%)  6 5/936 (0.53%)  5
Respiratory event - Pulmonary effusion  1  33/974 (3.39%)  37 64/936 (6.84%)  81
Respiratory event - Respiratory failure  1  50/974 (5.13%)  56 75/936 (8.01%)  92
Vascular disorders     
Bleeding - Hemorrhage  1  145/974 (14.89%)  167 248/936 (26.50%)  297
Embolization including air/calcific valve material or Thrombus  1  15/974 (1.54%)  15 26/936 (2.78%)  27
Hypertension  1  6/974 (0.62%)  6 3/936 (0.32%)  3
Hypotension  1  14/974 (1.44%)  14 24/936 (2.56%)  25
Ischemia  1  13/974 (1.33%)  20 21/936 (2.24%)  24
Syncope  1  21/974 (2.16%)  22 20/936 (2.14%)  22
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%
PIIA: SAPIEN XT - 2 Year Control: SAVR - 2 Year
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   838/974 (86.04%)      864/936 (92.31%)    
Blood and lymphatic system disorders     
Anemia/Hemolytic anemia  1  168/974 (17.25%)  192 198/936 (21.15%)  219
Thrombocytopenia  1  120/974 (12.32%)  126 210/936 (22.44%)  217
Cardiac disorders     
Arrhythmia/Conduction system injury (defect)  1  284/974 (29.16%)  338 409/936 (43.70%)  507
Heart failure/CHF/Low output failure  1  71/974 (7.29%)  75 90/936 (9.62%)  101
Gastrointestinal disorders     
Gastro Intestinal event - Non-hemorrhagic  1  96/974 (9.86%)  108 125/936 (13.35%)  157
General disorders     
Edema  1  39/974 (4.00%)  40 53/936 (5.66%)  56
Miscellaneous - Other  1  62/974 (6.37%)  72 67/936 (7.16%)  81
Other  1  165/974 (16.94%)  213 175/936 (18.70%)  221
Infections and infestations     
Infection - Other  1  86/974 (8.83%)  96 84/936 (8.97%)  96
Infection - Respiratory infection  1  98/974 (10.06%)  112 101/936 (10.79%)  118
Infection - Urinary tract infection  1  133/974 (13.66%)  164 165/936 (17.63%)  198
Injury, poisoning and procedural complications     
Miscellaneous - Fall  1  80/974 (8.21%)  94 66/936 (7.05%)  76
Investigations     
Abnormal lab value  1  187/974 (19.20%)  260 257/936 (27.46%)  404
Musculoskeletal and connective tissue disorders     
Musculoskeletal - Pain  1  100/974 (10.27%)  121 90/936 (9.62%)  108
Psychiatric disorders     
Mental state change (not neurological) - Confusion  1  39/974 (4.00%)  42 63/936 (6.73%)  65
Renal and urinary disorders     
Genito-Urinary event - Non-hemorrhagic  1  47/974 (4.83%)  54 58/936 (6.20%)  64
Renal insufficiency or renal failure  1  214/974 (21.97%)  254 258/936 (27.56%)  297
Respiratory, thoracic and mediastinal disorders     
Respiratory event - Atelectasis  1  37/974 (3.80%)  37 51/936 (5.45%)  51
Respiratory event - Pneumothorax  1  4/974 (0.41%)  4 47/936 (5.02%)  49
Respiratory Event - Pulmonary Effusion  1  70/974 (7.19%)  75 178/936 (19.02%)  191
Vascular disorders     
Bleeding - Hemorrhage  1  285/974 (29.26%)  345 421/936 (44.98%)  500
Hypertension  1  74/974 (7.60%)  75 48/936 (5.13%)  49
Hypotension  1  56/974 (5.75%)  62 97/936 (10.36%)  102
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 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: Tenley Koepnick
Organization: Edwards Lifesciences
EMail: Tenley_Koepnick@edwards.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01314313    
Other Study ID Numbers: 2010-12-PIIA
First Submitted: March 7, 2011
First Posted: March 14, 2011
Results First Submitted: September 16, 2016
Results First Posted: August 14, 2018
Last Update Posted: August 28, 2019