Catheter Ablation for Atrial Fibrillation and Heart Failure



Status:Completed
Conditions:Atrial Fibrillation, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:April 2010
End Date:March 2014
Contact:Suneet Mittal, MD
Email:smittal@chpnet.org
Phone:212-523-4017

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Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study


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.


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
We found this trial at
2
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New York, New York 10025
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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