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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080006 / PAS002 |
| Date Original Protocol Accepted |
04/07/2009
|
| Date Current Protocol Accepted |
12/05/2013
|
| Study Name |
Chronic Lead Performance
|
| Device Name |
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study utilizes the Medtronic¿s Post-Approval Network Product
Surveillance Registry (PSR) designed to conduct non-randomized, active prospective post-market Surveillance. The Registry is sponsored by Medtronic and is comprised of a global network of hospitals, clinics and clinicians from which reliable ¿real world¿ product safety and patient clinical outcome information is generated.
|
| Study Population |
The study will consist of patients rolled over from the pre-market study and patients newly enrolled in the postapproval study all tracked within the System Longevity Study sponsor registry. These are patients indicated for chronicpacing and sensing in the left ventricle via thecardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy system.
|
| Sample Size |
1778 patients, 60 sites
|
| Key Study Endpoints |
The endpoints include the complication free rate will be estimated based on the chronic (> 30 days post implant) clinical adverse events including 1) failure to capture, 2) failure to sense, 3) Undersensing, 4) Threshold rise, 5) Oversensing, 6) Abnormal pacing impedance, 7) Lead insulation breach, 8) Lead conductor fracture, 9) Extracardiac stimulation, 10) Cardiac perforation, 11) Lead dislodgement, and 12) Structural Lead Failure.
|
| Follow-up Visits and Length of Follow-up |
Patients will be followed every six months for 5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1847
|
| Actual Number of Sites Enrolled |
124
|
| Patient Follow-up Rate |
52.41%
|
| Final Safety Findings |
The Chronic Performance Post-Approval Study met the primary endpoint demonstrating that the Medtronic Attain Ability 4196 lead-related complication-free rate is greater than 92.5% at five years implant with a 95.68% complicate-free rate at five years with a lower 2-sided confidence bound of 94.47% and an upper 2-sided confidence bound of 96.63%.
|
| Final Effect Findings |
As of R073, there were a total of 82 threshold rises at implant and 133 threshold rises at follow-up. Of those, 72 threshold rises from 31 different leads were reported as lead related complications, including 22 were counted against the complication-free survival estimate (CFSE) based on the study protocol definition. There were 20 impedances out of range at implant and 9 impedances out of range at follow- up. One impedance out of range was reported as a lead related complication.
|
| Study Strengths & Weaknesses |
The Chronic Performance PAS met the primary endpoint and provided long-term data. However, the final attrition rate was higher than the initially anticipated attrition rate (71% vs 40%).
|
| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoint, follow-up visits etc.), final results, study strengths and limitations of the PAS.
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