Catheter Ablation for Atrial Fibrillation and Heart Failure

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01082601
• Other study ID #: 09-137
• Status: Withdrawn
• Phase: N/A
• First received: March 5, 2010
• Last updated: October 15, 2012
• Start date: April 2010
• Est. completion date: January 2012

Study information

• Verified date: June 2011
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• Pulmonary Vein Isolation (PVI)
Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.

Locations

Country	Name	City	State
United States	St.Luke's-Roosevelt Hospital	New York	New York
United States	The Valley Hospital	Ridgewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in LVESV by 15% or more from baseline at 6 months		6 months	No
Secondary	Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram		6 months	No
Secondary	NYHA Class		6 months	No
Secondary	Quality of Life		6 months	No
Secondary	Six minute hall walk test		6 months	No
Secondary	Hospitalization for HF	Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality	one year	No
Secondary	Absence of Atrial fibrillation		one year	No