- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01082601
Catheter Ablation for Atrial Fibrillation and Heart Failure
October 15, 2012 updated by: St. Luke's-Roosevelt Hospital Center
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Withdrawn
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Ridgewood, New Jersey, United States, 07450
- The Valley Hospital
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New York
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New York, New York, United States, 10025
- St.Luke's-Roosevelt Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Improvement in LVESV by 15% or more from baseline at 6 months
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: 6 months
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6 months
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Remodeling as demonstrated by atrial & ventricular dimensions on echocardiogram
Time Frame: 6 months
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6 months
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NYHA Class
Time Frame: 6 months
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6 months
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Six minute hall walk test
Time Frame: 6 months
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6 months
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Hospitalization for HF
Time Frame: one year
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Composite hospitalization for HF,thromboembolic complications, major bleeding or all cause mortality
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one year
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Absence of Atrial fibrillation
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Suneet Mittal, MD, St. Luke's-Roosevelt Hospital Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-137
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
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Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
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AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
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Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
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Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
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Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
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St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
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R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Pulmonary Vein Isolation (PVI)
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AtriCure, Inc.Active, not recruitingAtrial FibrillationUnited States
-
University of Texas Southwestern Medical CenterMedtronicCompletedAtrial FibrillationUnited States
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ElsanRecruitingPersistent Atrial FibrillationFrance
-
Imperial College LondonCompletedParoxysmal Atrial FibrillationUnited Kingdom
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Dignity Health Medical FoundationBeth Israel Deaconess Medical Center; Brigham and Women's Hospital; St. Luke's... and other collaboratorsActive, not recruitingPersistent Atrial FibrillationUnited States
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University of PennsylvaniaWithdrawnTypical Atrial Flutter | Risk Factors With Future Development of Atrial FlutterUnited States
-
Liverpool Heart and Chest Hospital NHS Foundation...UnknownAtrial FibrillationUnited Kingdom
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University of LeipzigRecruiting
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Abbott Medical DevicesCompletedParoxysmal Atrial Fibrillation | Persistent Atrial FibrillationUnited States, Belgium, Germany, Netherlands
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Chinese University of Hong KongTerminatedAtrial FibrillationHong Kong