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QuickFlex Micro Left Ventricular Lead Post Approval 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: NCT01179477
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Heart Failure
Intervention Device: Implantation of a QuickFlex® μ Model 1258T LV Lead
Enrollment 1930
Recruitment Details Per the clinical investigation protocol, IDE subjects (n=54) who did not consent to roll over into the post approval study (PAS) at sites participating in the post approval study, were included in primary endpoint analyses. Since these subjects are not enrolled into the PAS, they are not reflected in the participant flow.
Pre-assignment Details  
Arm/Group Title Subjects Implanted With a New QuickFlex μ Lead
Hide Arm/Group Description Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years.
Period Title: Overall Study
Started 1930
Completed 843
Not Completed 1087
Reason Not Completed
Death             542
Unsuccessful implant             80
Non-death withdrawal             438
Did not complete final visit             27
Arm/Group Title Subjects Implanted With a New QuickFlex μ Lead
Hide Arm/Group Description Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ IDE study were enrolled into the post-approval study. All successfully enrolled subjects were followed every six months for a period of five years.
Overall Number of Baseline Participants 1930
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1930 participants
68.7  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1930 participants
Female
529
  27.4%
Male
1401
  72.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1930 participants
Asian
8
   0.4%
American Indian or Alaska Native
2
   0.1%
Black or African American
197
  10.2%
Hispanic or Latino
67
   3.5%
Native Hawaiian/Pacific Islander
2
   0.1%
Other
8
   0.4%
White
1646
  85.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1930 participants
1930
Left Ventricular Ejection Fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of blood ejected
Number Analyzed 1930 participants
25.1  (7.6)
[1]
Measure Description: LVEF is percent of blood ejected from left ventricle
Intrinsic QRS duration  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 1930 participants
152.0  (25.2)
New York Heart Association (NYHA) Classification at Baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1930 participants
Class I
19
   1.0%
Class II
175
   9.1%
Class III
1672
  86.6%
Class IV
61
   3.2%
Unknown
3
   0.2%
[1]
Measure Description:

NYHA Functional Classification has 4 categories:

Class I (least severe) - no limitation of physical activity Class II - slight limitation of physical activity Class III - marked limitation of physical activity Class IV (most severe) - unable to carry on any phyiscal activity without discomfort

Cardiomyopathy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1930 participants
Ischemic
1131
  58.6%
Non-ischemic
799
  41.4%
1.Primary Outcome
Title Percent of Participants Alive and Without a Left Ventricular Lead-related Complication
Hide Description Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for Primary Endpoint #1 includes newly enrolled and IDE rollover subjects with an attempted implant of the QuickFlex μ LV lead (n=1,930) and subjects from the IDE sites that agreed to participate in the post-approval study, but did not consent to rollover into the post-approval study (n=54), for a total of 1,984 subjects.
Arm/Group Title Subjects Implanted With a New QuickFlex μ Lead
Hide Arm/Group Description:
Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
Overall Number of Participants Analyzed 1984
Measure Type: Count of Participants
Unit of Measure: Participants
1902
  95.9%
2.Primary Outcome
Title Left Ventricular Bipolar Pacing Capture Threshold
Hide Description Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects included in this analysis are only those who have left ventricular bipolar pacing capture threshold values reported a the 5-year visit. Of the 843 who completed the 5 year visit, only 774 had analzable data.
Arm/Group Title Subjects Implanted With a New QuickFlex μ Lead
Hide Arm/Group Description:
Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
Overall Number of Participants Analyzed 774
Mean (Standard Deviation)
Unit of Measure: Volts
2.04  (1.6)
Time Frame Complications and observations post implant through 5 years
Adverse Event Reporting Description

Complications are considered serious adverse events. A complication is an event caused by or associated with the study device, system component(s) and/or procedure that requires invasive intervention (e.g. post-implant lead dislodgement requiring repositioning).

An observation is an event caused by or associated with the study device, system component(s) and/or procedure that does not require invasive intervention (e.g. over-sensing or loss of pacing capture requiring reprogramming)

 
Arm/Group Title Subjects Implanted With a New QuickFlex μ Lead
Hide Arm/Group Description Subjects implanted with a new QuickFlex μ lead and subjects previously enrolled in the QuickFlex μ Investigational Device Exemption (IDE) study were enrolled into the PAS study. All successfully enrolled subjects were followed every six months for a period of five years.
All-Cause Mortality
Subjects Implanted With a New QuickFlex μ Lead
Affected / at Risk (%)
Total   542/1930 (28.08%)    
Hide Serious Adverse Events
Subjects Implanted With a New QuickFlex μ Lead
Affected / at Risk (%) # Events
Total   258/1930 (13.37%)    
Infections and infestations   
Infection  [1]  24/1930 (1.24%)  24
Erosion   2/1930 (0.10%)  2
Endocarditis   1/1930 (0.05%)  1
RV Endocarditis   1/1930 (0.05%)  1
RV Infection   1/1930 (0.05%)  1
Injury, poisoning and procedural complications   
Lead Dislodgement or Migration   62/1930 (3.21%)  63
Diaphragmatic/Phrenic Nerve Stimulation   16/1930 (0.83%)  16
Dizziness   1/1930 (0.05%)  1
Endocarditis   1/1930 (0.05%)  1
Induced Atrial or Ventricular Arrhythmias   1/1930 (0.05%)  1
Pain/Discomfort At Incision Site   2/1930 (0.10%)  2
Pericardial Effusion   2/1930 (0.10%)  2
RA Cardiac/Coronary Sinus Perforation   1/1930 (0.05%)  1
RA Diaphragmatic/Phrenic Nerve Stimulation   1/1930 (0.05%)  1
RV Lead Dislodgement or Migration   31/1930 (1.61%)  32
RV Cardiac/Coronary Sinus Perforation   3/1930 (0.16%)  3
RV Cardiac Tamponade   1/1930 (0.05%)  1
RV Pectoral Stimulation   1/1930 (0.05%)  1
Procedure Hematoma/Seroma   9/1930 (0.47%)  9
Procedure Pneumothorax/Hemothorax   7/1930 (0.36%)  7
Procedural Pericardial Effusion   3/1930 (0.16%)  3
Procedural Cardiac/Coronary Sinus Perforation   2/1930 (0.10%)  2
Procedural Cardiac Arrest   1/1930 (0.05%)  1
Procedural Cardiac Tamponade   1/1930 (0.05%)  1
Procedural Deep Vein Thrombosis   1/1930 (0.05%)  1
Procedural Device Migration   1/1930 (0.05%)  1
Procedural Guidewire Stuck In LV Lead   1/1930 (0.05%)  1
Procedural Lead Dislodgement or Migration   1/1930 (0.05%)  1
Procedural Pleural Effusion   1/1930 (0.05%)  1
Procedural Skin Injury At PG Pocket   1/1930 (0.05%)  1
Product Issues   
Loss of Capture   9/1930 (0.47%)  9
Elevated Pacing Thresholds   8/1930 (0.41%)  8
Abnormal LV Lead Pacing Impedance <= 200 OHMS or >= 2000 OHMS   3/1930 (0.16%)  3
Lead Fracture   1/1930 (0.05%)  1
Lead Insulation Damage   1/1930 (0.05%)  1
Premature Battery Depletion   8/1930 (0.41%)  8
Suspected Generator Malfunction   4/1930 (0.21%)  4
LV Lead Loss of Capture   1/1930 (0.05%)  1
RA Lead Dislodgement or Migration   20/1930 (1.04%)  22
RA Abnormal Lead Impedance   4/1930 (0.21%)  4
RA Lead Insulation Damage   4/1930 (0.21%)  4
RA Loss of Capture   2/1930 (0.10%)  2
RA Atrial Lead Noise   1/1930 (0.05%)  1
RA Elevated Pacing Thresholds   1/1930 (0.05%)  1
RA Oversensing   1/1930 (0.05%)  1
RA Undersensing   1/1930 (0.05%)  1
RV Elevated Pacing Thresholds   9/1930 (0.47%)  9
RV Lead Fracture   7/1930 (0.36%)  7
RV Lead Insulation Damage   5/1930 (0.26%)  5
RV Abnormal Lead Impedance   4/1930 (0.21%)  4
RV Loss of Capture   2/1930 (0.10%)  2
RV Inappropriate Shock   1/1930 (0.05%)  1
RV Oversensing   1/1930 (0.05%)  1
RV Lead Unable to Defibrillate   1/1930 (0.05%)  1
RV Undersensing   1/1930 (0.05%)  1
Psychiatric disorders   
Twiddler Syndrome   3/1930 (0.16%)  4
Indicates events were collected by systematic assessment
[1]
Procedure Related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
Subjects Implanted With a New QuickFlex μ Lead
Affected / at Risk (%) # Events
Total   512/1930 (26.53%)    
Cardiac disorders   
System/Pulse Generator Related Therapy For Non-Ventricular Rhythm  [1]  23/1930 (1.19%)  27
System/Pulse Generator Related Idioventricular Rhythm Preventing Biventricular Pacing  [2]  1/1930 (0.05%)  1
RV Lead Related Therapy For Non-Ventricular Rhythm   6/1930 (0.31%)  6
Other Therapy For Non-Ventricular Rhythm   6/1930 (0.31%)  6
General disorders   
Other Pulmonary Edema   2/1930 (0.10%)  2
Infections and infestations   
Procedure Related Infection   4/1930 (0.21%)  4
Other Infection   1/1930 (0.05%)  2
Injury, poisoning and procedural complications   
LV Diaphragmatic/Phrenic Nerve Stimulation  [3]  145/1930 (7.51%)  164
LV Induced Atrial or Ventricular Arrhythmias  [3]  2/1930 (0.10%)  2
LV Lead Dislodgement or Migration  [3]  2/1930 (0.10%)  2
LV Cardiac/Coronary Sinus Dissection  [3]  1/1930 (0.05%)  1
LV Coronary Sinus or Cardiac Vein Thrombosis  [3]  1/1930 (0.05%)  1
RA Lead Related Lead Dislodgement or Migration   1/1930 (0.05%)  1
RA Lead Related Myopotential Sensing   1/1930 (0.05%)  1
RV Lead Related Bilateral Pleural Effusion   1/1930 (0.05%)  1
RV Lead Related Myopotential Sensing   1/1930 (0.05%)  1
RV Lead Related Pectoral Stimulation   1/1930 (0.05%)  1
Procedure Related Hematoma/Seroma   33/1930 (1.71%)  33
Procedure Related Cardiac/Coronary Sinus Dissection   12/1930 (0.62%)  12
Procedure Related Atrial Arrhythmia   3/1930 (0.16%)  3
Procedure Related Pericardial Effusion   3/1930 (0.16%)  3
Procedure Related Bleeding And/or Hemoptysis   2/1930 (0.10%)  2
Procedure Related Cardiac Vein Thrombus   2/1930 (0.10%)  2
Procedure Related Part of The Delivery Tool Was Left In The Coronary Sinus/ Ventricle   2/1930 (0.10%)  2
Procedure Related Pneumothorax/Hemothorax   2/1930 (0.10%)  2
Procedure Related Pulmonary Edema   2/1930 (0.10%)  2
Procedure Related Renal Failure or Injury   2/1930 (0.10%)  2
Procedure Related Acute Left Arm Thrombophlebitis   1/1930 (0.05%)  1
Procedure Related Cardiac/Coronary Sinus Perforation   1/1930 (0.05%)  1
Procedure Related Decompensated Heart Failure   1/1930 (0.05%)  1
Procedure Related Device Incision Erythema   1/1930 (0.05%)  1
Procedure Related Excessive Bleeding   1/1930 (0.05%)  1
Procedure Related Frozen Shoulder   1/1930 (0.05%)  1
Procedure Related High DFT's   1/1930 (0.05%)  1
Procedure Related Hypotension   1/1930 (0.05%)  1
Procedure Related Hypotension Requiring Medical Intervention During CRT-D Implant   1/1930 (0.05%)  1
Procedure Related Myocardial Infarction   1/1930 (0.05%)  1
Procedure Related Pericarditis   1/1930 (0.05%)  1
Other Pericardial Effusion   3/1930 (0.16%)  3
Other Induced Atrial or Ventricular Arrhythmias   2/1930 (0.10%)  2
Product Issues   
LV Lead Elevated Pacing Thresholds  [3]  214/1930 (11.09%)  221
LV Loss of Capture  [4]  19/1930 (0.98%)  20
Abnormal LV Lead Pacing Impedance <= 200 Ω or >= 2000 Ω  [3]  16/1930 (0.83%)  17
LV Lead Insulation Damage  [3]  1/1930 (0.05%)  1
System/Pulse Generator Related Failed ICD Shock  [2]  1/1930 (0.05%)  1
System/Pulse Generator Related Pacemaker Mediated Tachycardia  [2]  1/1930 (0.05%)  1
RA Lead Related Oversensing   9/1930 (0.47%)  9
RA Lead Related Abnormal Lead Impedance   5/1930 (0.26%)  5
RA Lead Related Atrial Lead Noise   3/1930 (0.16%)  3
RA Lead Related Elevated Pacing Thresholds   3/1930 (0.16%)  3
RA Lead Related Lead Insulation Damage   3/1930 (0.16%)  3
RA Lead Related Loss of Capture   2/1930 (0.10%)  2
RA Lead Related Lead Fracture   1/1930 (0.05%)  1
RA Lead Related Undersensing   1/1930 (0.05%)  1
RV Lead Related Abnormal Lead Impedance   3/1930 (0.16%)  3
RV Lead Related Lead Insulation Damage   2/1930 (0.10%)  2
RV Lead Related Elevated Pacing Thresholds   1/1930 (0.05%)  1
RV Lead Related Lead Externalization   1/1930 (0.05%)  1
RV Lead Related Oversensing   1/1930 (0.05%)  1
Indicates events were collected by systematic assessment
[1]
(System / PG / Other Leads/ Procedure)
[2]
System / PG / Other Leads/ Procedure
[3]
LV Lead Related Observations
[4]
Lead Related Observations
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: Clay Cohorn, Clinical Program Director
Organization: Abbott
Phone: 972-309-8087
EMail: clay.cohorn@abbott.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01179477    
Other Study ID Numbers: CRD561
First Submitted: August 9, 2010
First Posted: August 11, 2010
Results First Submitted: November 6, 2018
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019