|
|
| 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)
|
| 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
|
