Catheter Ablation for Atrial Fibrillation and Heart Failure

This study has been withdrawn prior to enrollment.
(no enrollment)
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01082601
First received: March 5, 2010
Last updated: October 15, 2012
Last verified: June 2011
  Purpose

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 Intervention
Congestive Heart Failure
Atrial Fibrillation
Arrhythmia
Procedure: Pulmonary Vein Isolation (PVI)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Improvement in LVESV by 15% or more from baseline at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • NYHA Class [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Six minute hall walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Hospitalization for HF [ Time Frame: one year ] [ Designated as safety issue: No ]
    Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality

  • Absence of Atrial fibrillation [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Catheter Ablation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082601

Locations
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
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
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01082601     History of Changes
Other Study ID Numbers: 09-137
Study First Received: March 5, 2010
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Catheter Ablation
Atrial Fibrillation
Congestive heart failure

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Failure
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014