Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-26 @ 12:12 AM
Study NCT ID:
NCT01872234
Status:
TERMINATED
Last Update Posted:
2014-04-30
First Post:
2013-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MADIT ASIA Cardiac Resynchronization Trial
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
MADIT ASIA Cardiac Resynchronization Trial (MADIT-ASIA)
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study encountered significant difficulties in patient enrollment.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MADIT-ASIA
Brief Summary:
The purpose of this trial or study is to determine if pacemaker therapy can be a beneficial alternative to conventional medical therapy in patients with a history of moderate heart failure. The investigators are looking to enroll approximately 180 people in this trial. Patients will be randomized in two groups. One group will be implanted with a pacemaker and will continue to receive conventional medical therapy as prescribed by their doctor. The second group will continue to receive conventional medical therapy as prescribed by their doctor and will not be implanted with a pacemaker. Clinical histories, physical exams, and external device testing will be collected both at the time of enrollment in the trial and during follow-up study visits. Patients who enter the study will be seen for study visits at 1 month, 3 and 6 months.
Detailed Description:
MADIT-ASIA is a multicenter, prospective, randomized clinical study. The primary aim is to show that two lead CRT-P with guideline-based optimal pharmacological therapy is associated with a significantly greater improvement in left ventricular ejection fraction (LVEF) at 6 months compared with guideline-based optimal pharmacologic therapy only.
The study will be initially conducted at approximately 25 centers in up to 9 countries in Asia including India, Thailand, Taiwan, Malaysia, China, Japan, South Korea and Singapore. If necessary, more sites may be invited to participate to meet the enrollment goal.
Following randomization, subjects will have scheduled clinic visit follow-ups at 1, 3 and 6-month intervals. Relevant event history, cardiac medications, physical assessment, device interrogation/programming status and adverse events will be collected at each follow-up visit. At the 6-month visit, a repeat echocardiogram and a 12-lead ECG will be obtained. Subjects will be followed through the 6 month visit. After that, subjects will have a safety follow up contact at the end of the study. The study will end when the last randomized subject reaches the 6 months visit.
The study will be initially conducted at approximately 25 centers in up to 9 countries in Asia including India, Thailand, Taiwan, Malaysia, China, Japan, South Korea and Singapore. If necessary, more sites may be invited to participate to meet the enrollment goal.
Following randomization, subjects will have scheduled clinic visit follow-ups at 1, 3 and 6-month intervals. Relevant event history, cardiac medications, physical assessment, device interrogation/programming status and adverse events will be collected at each follow-up visit. At the 6-month visit, a repeat echocardiogram and a 12-lead ECG will be obtained. Subjects will be followed through the 6 month visit. After that, subjects will have a safety follow up contact at the end of the study. The study will end when the last randomized subject reaches the 6 months visit.
Study Oversight
Has Oversight DMC:
True
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?: