Heart Failure Clinical Trial

Catheter Ablation for Atrial Fibrillation and Heart Failure

Summary

To compare heart function, symptoms, exercise capacity and quality of life in patients with Congestive Heart Failure (CHF) and Atrial Fibrillation (AF)before and after catheter ablation.

Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use of antiarrhythmic drugs, in AF and CHF improves heart failure status.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age 18 years to 80 years
Clinical diagnosis of CHF based on symptoms (Shortness of breath, fatigue, peripheral edema)
Systolic left ventricular dysfunction with ejection fraction 40% or less
NYHA Class I, II or III heart failure
Paroxysmal AF(2 or more episodes in one month) that terminate within 7 days:or persistent AF (more than 7 days or less than 7 days but terminated with pharmacologic or electrical cardioversion).
Willing and able to sign informed consent

Exclusion Criteria:

Previous ablation
Left atrial size greater than 60mm(parasternal view on transthoracic echocardiogram)
AF episodes triggered by another uniform arrhythmia(e.g.atrial flutter or atrial tachycardia)
Active alcohol or drug abuse, which may be causative of AF
Severe valvular disease requiring surgical repair
Myocardial infarction within 6 months of enrollment
Abnormality that prevents catheter introduction
Coronary surgical revascularization or other cardiac surgery within 6 months of enrollment
Patients in whom heart transplant expected with 6 months
AF deemed secondary to a transient or correctable cause (e.g.electrolyte imbalance ,trauma,recent surgery,,infection, toxic ingestion or endocrinopathy
Pregnancy or women of child bearing potential & not on reliable method of birth control
Contraindication to Warfarin therapy or other bleeding diathesis
Participation in another clinical trial
Inaccessable to follow-up
Life expectancy of less than 24 months caused by reasons other than heart disease
Renal failure requiring dialysis
Decompensated CHF within 48 Hours of enrollment
Second or third degree AV block or sinus pause greater than 3 seconds, resting heart rate less 30 bpm without a permanent pacemaker
A history of drug induced Torsades de Pointes or congenital long QT syndrome
Currently responding to antiarrhythmic drug therapy
Uninterrupted AF for more than 12 months prior to randomization unless sinus rhythm maintained for 24 hours or longer.
Unwilling or unable to sign informed consent

Study is for people with:

Heart Failure

Study ID:

NCT01082601

Recruitment Status:

Withdrawn

Sponsor:

St. Luke's-Roosevelt Hospital Center

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There are 2 Locations for this study

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The Valley Hospital
Ridgewood New Jersey, 07450, United States
St.Luke's-Roosevelt Hospital
New York New York, 10025, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Study ID:

NCT01082601

Recruitment Status:

Withdrawn

Sponsor:


St. Luke's-Roosevelt Hospital Center

How clear is this clinincal trial information?

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