Evaluation fo Resynchronization Therapy for Heart Failure (EARTH)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Montreal Heart Institute
- Enrollment
- 120
- Locations
- 11
- Primary Endpoint
- The primary endpoint is total exercise duration at a constant submaximal load (ETT submaximal load is defined as 75% of peak exercise during the baseline metabolic evaluation)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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, cardiac resynchronization therapy (CRT) has very recently been shown to be effective to improve functional class, quality of life and exercise tolerance of the patients with the most severe symptoms of heart failure and a prolonged duration of the QRS on the 12-lead Electrocardiography (ECG).
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 persists concerning the optimal configuration for cardiac pacing in these patients. Right ventricular pacing alone has been shown to be deleterious in some patient populations. The benefits of biventricular pacing in heart failure patients may be due primarily to left ventricular stimulation and may, in some patients, be decreased by the presence of simultaneous RV stimulation. Preliminary data from our own animal work suggest that in the majority of cases, LV stimulation alone is better than RV stimulation, and that BiV stimulation represents an intermediary situation between LV and RV stimulation.
Investigators
Bernard Thibault
MD
Montreal Heart Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
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)?
Outcomes
Primary Outcomes
The primary endpoint is total exercise duration at a constant submaximal load (ETT submaximal load is defined as 75% of peak exercise during the baseline metabolic evaluation)
Time Frame: one year
Secondary Outcomes
- Clinical, electrical, echocardiographic, MUGA scan endpoints, Neuro-hormones(one year)