|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P010012 S230/ PAS002 |
Date Original Protocol Accepted |
09/27/2011
|
Date Current Protocol Accepted |
09/27/2011
|
Study Name |
MADIT-CRT Registry
|
Device Name |
BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)
|
Clinical Trial Number(s) |
NCT00180271
|
General Study Protocol Parameters |
Study Design |
Randomized Clinical Trial
|
Data Source |
New Data Collection
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Analytical
|
Study Population |
Adult: >21
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
394 patients
|
Actual Number of Sites Enrolled |
49 centers
|
Patient Follow-up Rate |
98.98% (390/394)
|
Final Safety Findings |
The rate of device system related adverse events (number of Events/100 Device Months) is slightly higher in the CRT-D compared to ICD (0.54 in CRT-D vs. 0.36 in ICD) in this PAS Registry that is expected and consistent to the findings in the IDE study. The Registry showed a higher rate of early ERI (elective replacement indicator) in CRT-D group (4.1%) compared to ICD only group (2.7%) with longer follow-up indicating rapid battery depletion secondary to increased amount of pacing needed over time for cardiac resynchronization. The incidence of device-related adverse events for CRT-D in the Registry is in the acceptable range.
|
Final Effect Findings |
The cohort of combined IDE and Registry for followed out through 5 years showed CRT-D reduced a 32% relative risk of all-cause mortality in LBBB subpopulation as compared to ICD (p=0.028). CRT-D was also associated with significant reduction in the risk of a first heart failure event and recurrent heart failure events in both the LBBB subsets and all subjects in combined IDE and Registry.
|
Study Strengths & Weaknesses |
Strength: long-term follow-up (5 years) Weakness: small sample size (394 patients) insufficient to test statistical significance in crossover analysis and efficacy analysis
|
Recommendations for Labeling Changes |
NO
|