|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P010012 S230/ PAS001 |
Date Original Protocol Accepted |
09/16/2010
|
Date Current Protocol Accepted |
01/18/2013
|
Study Name |
MADIT-CRT ACC NCDR
|
Device Name |
BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)
|
Clinical Trial Number(s) |
NCT00180271
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
External Registry
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Analytical
|
Study Population |
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
Prospective Cohort Study
|
Study Population |
Patients in the NCDR ICD Registry will be identified, who, at the time of device implant were diagnosed with one of the following: NYHA functional class II with non-ischemic or ischemic cardiomyopathy OR who are NYHA functional class I with ischemic cardiomyopathy
AND Have left ventricular dysfunction (EF ≤30%), prolonged intraventricular conduction (QRS ≥ 130 ms), and with a LBBB
These Registry patients will be further split into the following patient cohorts for the purposes of analysis. CRT-D group: Patients implanted with a Boston Scientific CRT-D device after the MADIT-CRT indication approval date. ICD group: Patients implanted with a Boston Scientific ICD; either, (a) after the MADIT-CRT indication approval date, or, (b) before the MADIT CRT indication approval date.
|
Sample Size |
A minimum of 1300 patients who meet the specified criteria; have been implanted with a Boston Scientific CRT-D device followed for a minimum of 5 years. A minimum of 1300 patients who meet the specified criteria; have been implanted with a Boston Scientific ICD device followed for a minimum of 5 years. A minimum of 500 Class I patients who meet the specified criteria, including a minimum of 225 who have been implanted with a with a Boston Scientific CRT-D device, have been identified and followed for a minimum of 5 years.
|
Key Study Endpoints |
The primary endpoint for the study is to evaluate the /real-world/ effect of CRT-D, compared to ICD, on the time-to-all-cause mortality over a period of 5 years.
|
Follow-up Visits and Length of Follow-up |
5-years post-implant. Progress reports will be generated every 12 months and will include: demographics, mortality, and procedural related adverse events.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
ICD Historical Cohort: 998 ICD Concurrent Cohort: 1359 CRT-D Cohort: 7617 (207 NYHA functional Class I)
|
Actual Number of Sites Enrolled |
n/a
|
Patient Follow-up Rate |
Mean follow-up time for each cohort: 95 months for ICD historical cohort 54 months for ICD concurrent cohort 46 months for CRT-D cohort
|
Final Safety Findings |
Primary Objective Outcome: Rate of 60-month mortality: ICD historical cohort = 31.6% ICD concurrent cohort = 26.9% CRT-D cohort = 15.2% The benefit of CRT-D is consistently observed in all three pre-specified subgroups (further stratified into seven subgroups). A statistically significant benefit of CRT-D vs. ICD was observed in six of seven subgroups: NYHA Class and ischemic status at implant (Ischemic Class I, Ischemic Class II, Non-Ischemic Class II), Gender (Female, Male), the presence (or absence) of a HF hospitalization prior to device implant (prior HF diagnosis, no prior HF diagnosis) The difference in mortality between CRT-D and ICD patients in the NYHA Class I Ischemic subgroup failed to achieve statistical significance (p = 0.285) due to smaller sample and effect sizes than those observed in the NYHA Class II patients. However, the effect size observed in Class I patients does trend toward significance.
|
Final Effect Findings |
n/a
|
Study Strengths & Weaknesses |
Strengths: MADIT-CRT PAS 1 is a real-world evidence study that showed long-term mortality benefits of CRT-D in a MADIT-CRT (LBBB) patient population compared to ICD. Weaknesses: Data collection was slow as the study relied on the NCDR ICD registry and National Death Index for data collection. The use of the NCDR ICD registry was originally mandated by CMS, but no longer required as of 2018.
|
Recommendations for Labeling Changes |
Yes
|
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
|