|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050023 S107/ PAS001 |
| Date Original Protocol Accepted |
05/06/2017
|
| Date Current Protocol Accepted |
|
| Study Name |
MPP QP-ExCELs Sub-Study PAS
|
| Device Name |
Defibrillator, Implantable, Dual Chamber, Automatic Implantable Cardioverter with Cardiac Resynchronization
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Confirm long-term safety of the Biotronik Sentus OTW QP left ventricular pacing leads. The evaluation of safety will be freedom from Sentus QP related complications at 5 years post-implant.
|
| Study Population |
CRT-eligible Heart Failure patients
|
| Sample Size |
Postmarket Sample Size Required: 979
Postmarket Sample Size Required including attrition = 1754
|
| Key Study Endpoints |
Primary Endpoint: The purpose is to evaluate the long-term Sentus related complication-free rate through 5 years post-implant.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
Number of study sites enrolled 8 Sites
Number of subjects enrolled 12 Subjects
Follow-up rate Two (2) out of the 12 enrolled subjects reached the 3-month follow-up window and completed the 3-month follow-up visit. Therefore, 100% follow-up rate at 3 months. None of the 12 subjects reached the 6-month follow-up window.
Summary of Interim Results No study data are available for testing the primary hypothesis and estimating the defined metrics for the secondary endpoints.
Strengths and Weaknesses Study strengths and weaknesses cannot be assessed with this report given the study duration and little study data available.
|
| Actual Number of Patients Enrolled |
A total of 53 subjects were enrolled.
|
| Actual Number of Sites Enrolled |
A total of 26 study sites were enrolled.
|
| Patient Follow-up Rate |
The overall follow-up compliance was 97.16%.
|
| Final Safety Findings |
There were 4 events reported by the site which were classified as attributable to the MPP feature. All four events were due to extracardiac stimulation, and resolved with device programming. At the time of this report, there have been 3 subject deaths adjudicated by the
CEC. All death events have been adjudicated as cardiovascular death events. In total, 7 subjects had a total of 11 adjudicated adverse events. There were 9 events adjudicated as cardiovascular hospitalization and two events were collected and adjudicated to be non system related/non protocol
defined events.
|
| Final Effect Findings |
When comparing the improvement rate (35.6%) to the goal (3%), it was determined that there was a statistically significant difference (p-value <.0001) compared to the adjusted alpha of 0.0026 for the interim analysis. This result indicates the MPP Sub-Study had a superior responder improvement rate compared to the performance goal. Overall, there were no subjects reported with an MPP system related adverse event requiring additional invasive intervention to resolve. AE-free rate was 100%.
|
| Study Strengths & Weaknesses |
Overall, the results of the MultiPole Pacing Clinical Study indicate that the MPP feature is effective at converting a percentage of CRT non-responders to responders (35.6%) over 6-months of follow-up. Due to the non-randomized study design and small sample size of the MPP Sub-Study, these results should be interpreted with caution. Since delayed responders to CRT are not controlled for in this study, it is difficult to distinguish between true responders to MPP therapy and subjects who responded to an additional 6 months of bi-ventricular pacing.
|
| Recommendations for Labeling Changes |
Yes
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