Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180271
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2005-09-09
Brief Title:
MADIT-CRT Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MADIT-CRT
Brief Summary:
The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator ICD-cardiac resynchronization therapy CRT-D will reduce the risk of mortality and heart failure HF events by approximately 25 in subjects who are in New York Heart Association NYHA functional Class II with non-ischemic or ischemic cardiomyopathy and subjects who are in NYHA functional Class I with ischemic cardiomyopathy left ventricular dysfunction ejection fraction EF or 030 and prolonged intraventricular conduction QRS duration or 130 ms
Detailed Description:
In this study subjects will be randomized to CRT-D or ICD-only Randomization will be stratified by clinical center and ischemic status Approximately 60 of the subjects will be randomly assigned to receive a CRT-D with biventricular pacing and 40 will receive an ICD only Optimal pharmacological therapy for heart failure will be required in both treatment arms Length of follow-up for each subject will depend on the date of entry into the study since all subjects will be followed to a common study termination date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MADIT-CRT | None | None | None |