Status:
TERMINATED
MADIT ASIA Cardiac Resynchronization Trial
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
University of Rochester
Conditions:
Congestive Heart Failure
Left Bundle Branch Block
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 invest...
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 significan...
Eligibility Criteria
Inclusion
- Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
- Hospitalization for heart failure using the Framingham criteria requiring medical treatment more than 4 weeks ago but less than six months prior to randomization date
- Subject in sinus rhythm
- Subject with QRS duration \>110 milliseconds and left bundle branch block or incomplete left bundle branch block
- Subject with ejection fraction 36-50%
- Subject with ischemic or non-ischemic heart disease
- Subject on stable\* optimal pharmacologic therapy for the cardiac condition that is guideline-based and may include one or more of the following medications: Loop diuretics (e.g., furosemide, bumetanide, torsemide) unless the subject is not indicated, is contraindicated, or is intolerant of loop diuretics; Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) unless the subject failed, is not indicated, or is contraindicated for these therapies; Aldosterone antagonists unless the subject is not indicated, or is intolerant of aldosterone antagonists; Beta-blockers unless the subject is not indicated, contraindicated, or is intolerant of beta-blockers. The choice of selective or non-selective beta-blockers use is left to the Investigator's discretion \* For purposes of the study, "stable" is defined as beta blockers and ACE/ARB for at least three months prior to randomization, unless contraindicated or not tolerated, with stable doses for at least one month prior to randomization. It is permissible for diuretic and aldosterone antagonist dosage to have been adjusted as necessary.
Exclusion
- Subject with a currently implanted pacemaker, ICD, CRT-P or CRT-D generator or device component
- Subject with a history of spontaneous sustained VT\>160 bpm or VF
- Subject with permanent or chronic AF, or cardioversion for AF within the past 3 calendar months before randomization
- Subject with structural heart disease such as congenital heart disease, valvular heart disease, e.g., rheumatic valvular heart disease, amyloid heart disease, etc.
- Subject with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 3 calendar months before randomization
- Subject with enzyme positive myocardial infarction within the past 3 calendar months prior to randomization
- Subject with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
- Right bundle branch block or non-specific interventricular conduction delay
- Subject with second or third degree heart block
- Subject in New York Heart Association Class IV (symptoms of heart failure at rest)
- Subject who is pregnant or plans to become pregnant during the course of the trial. Note: Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization
- Subject with irreversible brain damage from pre-existing cerebral disease
- Subject with presence of any disease, other than the subject's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
- Subject with chronic renal disease with blood urea nitrogen (BUN) \> 50mg/dl (18 mmol/l) or creatinine \> 2.5mg/dl (221 µmol/l)
- Subject participating in any other clinical trial
- Subject unwilling or unable to cooperate with the protocol
- Subject who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
- Subject who does not anticipate being a resident of the area for the scheduled duration of the trial
- Subject unwilling to sign the consent for participation
- Subject whose physician does not allow participation
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01872234
Start Date
February 1 2014
End Date
April 1 2014
Last Update
April 30 2014
Active Locations (21)
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1
Grantham Hospital
Hong Kong, Hong Kong, China
2
Queen Mary Hospital
Hong Kong, Hong Kong, China
3
Prince of Wales Hospital
Shatin, Hong Kong, China
4
Fu Wai Hospital
Beijing, China