Catheter Ablation for Atrial Fibrillation and Heart Failure

St. Luke's-Roosevelt Hospital Center

Status: Withdrawn

Conditions: Arrhythmia; Atrial Fibrillation; Congestive Heart Failure

Treatments: Procedure: Pulmonary Vein Isolation (PVI)

Study type: Observational

Funder types: Other

Identifiers

NCT01082601

09-137

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Optimal Medical therapy

Description:

Subjects with Class I,IIor III congestive heart failure on optimal medical therapy. Planned catheter ablation for paroxysmal or persistent atrial fibrillation. Paroxysmal AF defined as recurrent AF(2 or more episodes in one month) that terminate within seven days. Persistent AF defined as sustained beyond seven days, or lasting less than seven days but requiring pharmacologic or electrical cardioversion.

Treatment:

Procedure: Pulmonary Vein Isolation (PVI)