Status:
COMPLETED
Evaluation of Resynchronization Therapy for Heart Failure (EARTH)
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
Abbott Medical Devices
Canadian Institutes of Health Research (CIHR)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Heart failure is a major health problem in Canada. Recent advances in medical and device therapy have helped to reduce the morbidity and mortality of patients with this problem. Among these treatments...
Detailed Description
Resynchronization of the failing ventricle is currently achieved by pacing the left and right ventricles simultaneously with specialized electrodes and a cardiac stimulator. However, controversy persi...
Eligibility Criteria
Inclusion
- Inclusion Criteria (for Greater and Lesser EARTH):
- Patient must answer "yes"
- Does the patient require an ICD or an ICD replacement?
- Does the patient have a documented LVEF less than or equal to 35% measured in the previous 6 months (without major concomitant clinical event)?
- Does the patient have a QRS duration \< 120 ms?
- Is the patient in sinus rhythm?
- Was the six-minute walk test distance less than 400 meters and limited by heart failure symptoms?
- Exclusion Criteria:
- Patient must have answered "NO" to all of the exclusion criteria
- Does the patient have:
- Indication for permanent ventricular pacing?
- Chronotropic insufficiency?
- Second or third degree AV block, either persistent or intermittent?
- A pacemaker or an ICD which is paced in ventricular chamber more than 5% of the time?
- Does the patient have a reversible cause of LV dysfunction such as post-partum cardiomyopathy, tachycardia induced cardiomyopathy, acute myocarditis or acute toxic cardiomyopathy (including acute alcoholic)?
- Did the patient have myocardial infarction or cardiac surgery in the 6 weeks preceding the pre-implant visit?
- Does the patient have a moderate or severe cardiac valve stenosis?
- Is the patient's capacity to walk is limited by reasons other than heart failure symptoms (e.g., angina, intermittent claudication, severe lung condition or arthritis)?
- Does the patient have severe coexisting illnesses making survival \> 6 months unlikely?
- Is the patient pregnant and/or nursing?
- Is the patient unable or unwilling to consent or to comply with follow-up requirements?
- Is the patient participating in another clinical study potentially interfering with the present trial?
- Does the patient have a resynchronization system in place?
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00901212
Start Date
October 1 2003
End Date
February 1 2010
Last Update
May 8 2012
Active Locations (11)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
St-Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
3
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
4
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7