Clinical trial NCT01082601: Catheter Ablation for Atrial Fibrillation and Heart Failure
Official title: Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congestive Heart Failure
Atrial Fibrillation
Arrhythmia
Keywords: Catheter Ablation
Atrial Fibrillation
Congestive heart failure
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2010-03-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in either the out patient or in hospital environment at St.Luke's-Roosevelt Hospital or The Valley Hospital, Ridgewood New Jersey, with systolic left ventricular dysfunction and atrial fibrillation. Class I-III CHF based on symptoms(shortness of breath,fatigue, peripheral edema and documented ejection fraction of less than 40%.

Brief 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.


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

Primary outcomes:
measure: Improvement in LVESV by 15% or more from baseline at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram
timeFrame: 6 months
measure: NYHA Class
timeFrame: 6 months
measure: Quality of Life
timeFrame: 6 months
measure: Six minute hall walk test
timeFrame: 6 months
measure: Hospitalization for HF
timeFrame: one year
measure: Absence of Atrial fibrillation
timeFrame: one year
Other outcomes:
Locations:
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: St.Luke's-Roosevelt Hospital
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Suneet Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References: