Catheter Ablation for Atrial Fibrillation and Heart Failure

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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation; Arrhythmia; Congestive Heart Failure
• Intervention / Treatment: Procedure: Pulmonary Vein Isolation (PVI)

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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%.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Optimal Medical therapy; 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.

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.; Other Names: Catheter Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in LVESV by 15% or more from baseline at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life		6 months
Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram		6 months
NYHA Class		6 months
Six minute hall walk test		6 months
Hospitalization for HF	Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality	one year
Absence of Atrial fibrillation		one year

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Investigators: Principal Investigator: Suneet Mittal, MD, St. Luke's-Roosevelt Hospital Center

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: March 5, 2010
• First Submitted That Met QC Criteria: March 5, 2010
• First Posted (Estimate): March 8, 2010

Study Record Updates

• Last Update Posted (Estimate): October 17, 2012
• Last Update Submitted That Met QC Criteria: October 15, 2012
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter Ablation; Congestive heart failure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: 09-137