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Catheter Ablation for Atrial Fibrillation and Heart Failure

Sponsor
St. Luke's-Roosevelt Hospital Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01082601
Collaborator
(none)
0
Enrollment
2
Locations
21
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pulmonary Vein Isolation (PVI)

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pulmonary Vein Isolation for Rhythm Control in Patients With Atrial Fibrillation and Left Ventricular Dysfunction: A Pilot Study
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in LVESV by 15% or more from baseline at 6 months [6 months]

    Secondary Outcome Measures

    1. Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram [6 months]

    2. NYHA Class [6 months]

    3. Quality of Life [6 months]

    4. Six minute hall walk test [6 months]

    5. Hospitalization for HF [one year]

      Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality

    6. Absence of Atrial fibrillation [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Valley Hospital Ridgewood New Jersey United States 07450
    2 St.Luke's-Roosevelt Hospital New York New York United States 10025

    Sponsors and Collaborators

    • St. Luke's-Roosevelt Hospital Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St. Luke's-Roosevelt Hospital Center
    ClinicalTrials.gov Identifier:
    NCT01082601
    Other Study ID Numbers:
    • 09-137
    First Posted:
    Mar 8, 2010
    Last Update Posted:
    Oct 17, 2012
    Last Verified:
    Jun 1, 2011
    Keywords provided by St. Luke's-Roosevelt Hospital Center
    Catheter Ablation
    Atrial Fibrillation
    Congestive heart failure
    Additional relevant MeSH terms:
    Heart Failure
    Atrial Fibrillation

    Study Results

    No Results Posted as of Oct 17, 2012