|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P890003 S179/ PAS001 |
| Date Original Protocol Accepted |
01/09/2012
|
| Date Current Protocol Accepted |
11/22/2013
|
| Study Name |
Chronic Lead Performance
|
| Device Name |
CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE
|
| 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 |
The Medtronic Post-Approval Network (PAN) is 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. Primary objective: To demonstrate that the complication- free probability is greater than 92.5% at five years post- implant for the high voltage DF4 connector.
|
| Study Population |
This study will consist of 1,778 patients implanted with a DF-
4 connector system, enrolled at one of approximately 150 centers globally. Subjects that meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
Inclusion Criteria
¿ Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
¿ Subject is implanted with a DF-4 connector system.
¿ Subject within 30 days of implant
Exclusion Criteria
¿ Subject who is, or will be inaccessible for follow-up at a site
¿ Subject with exclusion criteria required by local law
(Europe, Central Asia [ECA] only)
¿ Complete implant and follow-up data, including any product-related events at implant through the time of enrollment are unavailable
|
| Sample Size |
Accounting for attrition, a minimum enrollment of 1778 DF4 connectors are estimated to be required in order to achieve the desired sample size for the primary objective analysis at five years.
|
| Key Study Endpoints |
A list of lead-related events eligible to be included in the primary objective: Failure to capture, Failure to sense/ Undersensing, Oversensing, Threshold rise, Abnormal pacing impedance, Abnormal defibrillation impedance (RV and/or SVC coil), Lead insulation breach, Lead conductor fracture, Extra cardiac stimulation, Lead dislodgement, Cardiac perforation, Structural Lead Failure.
|
| Follow-up Visits and Length of Follow-up |
Subjects will be followed for a minimum of 5 years from their implant date. Therefore, the expected duration of the DF4 PAS is approximately 7 years.
Frequency of Follow-up
Assessments
Every 6 months
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1778
|
| Actual Number of Sites Enrolled |
104
|
| Patient Follow-up Rate |
38.5%
|
| Final Safety Findings |
The complication-free survival probability in this group was 98.6%.
|
| Final Effect Findings |
The sponsor presented Pacing Thresholds, Pacing and Defibrillation Impedance, and Sensing data for the subjects who remained in the study at 6 month intervals by lead type associated with the DF4 connector. The results confirm that the electrical performance of the DF4 connector leads is stable over time and within expected ranges.
|
| Study Strengths & Weaknesses |
A strength of this study is that the results reflect what is expected to be observed in routine clinical practice. A weakness includes the premature exit of some study sites and patients due to the longer-term nature of the study, thus limiting patient follow-up. Despite this barrier, the primary objective of the study was met, demonstrating the safety and efficacy of the DF4 connector.
|
| Recommendations for Labeling Changes |
Yes, completed.
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