Catheter Ablation for Atrial Fibrillation and Heart Failure
NCT ID: NCT01082601
Last Updated: 2012-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2010-04-30
2012-01-31
Brief Summary
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Hypothesis: Restoration and maintenance of sinus rhythm by catheter ablation, without the use of antiarrhythmic drugs, in AF and CHF improves heart failure status.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Pulmonary Vein Isolation (PVI)
Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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St. Luke's-Roosevelt Hospital Center
OTHER
Responsible Party
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Principal Investigators
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Suneet Mittal, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's-Roosevelt Hospital Center
Locations
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The Valley Hospital
Ridgewood, New Jersey, United States
St.Luke's-Roosevelt Hospital
New York, New York, United States
Countries
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Other Identifiers
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09-137
Identifier Type: -
Identifier Source: org_study_id