Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2014-02-28
2014-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Device Arm: Two Lead CRT-P
Intervention: Device: Two-lead CRT-P. Patients will be implanted with a two lead CRT-P system: right atrial lead, left ventricular lead and a dual chamber pacemaker. Patients in this group will also be under optimal pharmacologic therapy.
Two-lead CRT-P
The two lead CRT-P will consist of a dual chamber pacemaker, a right atrial lead and a left ventricular lead.
Control: Optimal Pharmacologic Therapy
The control group will be managed on optimal pharmacologic therapy only. They will not be implanted with a device.
No interventions assigned to this group
Interventions
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Two-lead CRT-P
The two lead CRT-P will consist of a dual chamber pacemaker, a right atrial lead and a left ventricular lead.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Rochester
OTHER
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Arthur J. Moss, M.D.
Role: PRINCIPAL_INVESTIGATOR
Univ. of Rochester Medical Center, Rochester, New York 14642, [email protected]
Locations
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Grantham Hospital
Hong Kong, Hong Kong, China
Queen Mary Hospital
Hong Kong, Hong Kong, China
Prince of Wales Hospital
Shatin, Hong Kong, China
Fu Wai Hospital
Beijing, , China
Zhejiang hospital Hangzhou
Hangzhou, , China
Zhongshan hospital Shanghai
Shanghai, , China
Medanta-Medicity
Gurgaon, Haryana, India
Fortis Escorts Health Institute, New Delhi
New Delhi, New Delhi, India
CARE Hospital Nampally, Hyderabad
Hyderabad, , India
Tokyo Women's Medical Univesity Hospital
Shinjuku, Tokyo, Japan
Okayama University Hospital
Okayama, , Japan
Institut Jantung Negara
Kuala Lumpur, , Malaysia
National Heart Center
Singapore, , Singapore
National University Heart Center Singapore
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Korea University Medical Center
Seoul, , South Korea
Seoul ASAN Medical Center
Seoul, , South Korea
Yonsei University Medical Center - Severance Hospital
Seoul, , South Korea
Chang Gung Memorial Hospital
Linkou District, , Taiwan
Her Majesty's Cardiac Center, Siriraj Hospital, Mahidol University
Bangkok, , Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, , Thailand
Countries
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Other Identifiers
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MADIT-ASIA
Identifier Type: -
Identifier Source: org_study_id