Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-10-01

Brief Summary

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This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.

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Detailed Description

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The purpose of the trial is to compare two different approved treatments for recently diagnosed AF: anti-arrhythmic medications and AF ablation. The study will be conducted to determine if one treatment is more effective than the other for patients with AF and heart failure. About 220 subjects with newly diagnosed AF from hospitals in the United States will take part in this study. Subjects will be randomized in a 1:1 fashion to either AF catheter ablation or anti-arrhythmic medication for treatment of AF. Both therapies are considered Standard of Care.

Conditions

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Congestive Heart Failure Left Ventricular Failure Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study randomizes subjects to already FDA approved treatment modalities. Approved anti-arrhythmic medications or AF ablation. There are no investigational drug or devices used.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AF catheter Ablation

Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF

Group Type ACTIVE_COMPARATOR

Catheter Ablation

Intervention Type DEVICE

During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF.

FDA approved anti arrhythmic drug

FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.

Group Type ACTIVE_COMPARATOR

FDA approved anti arrhythmic drug

Intervention Type DRUG

Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

Interventions

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Catheter Ablation

During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which "disconnects" the pathway of the AF.

Intervention Type DEVICE

FDA approved anti arrhythmic drug

Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines

Intervention Type DRUG

Other Intervention Names

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Pulmonary Vein Isolation

Eligibility Criteria

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Inclusion Criteria

* must be 18 years of age or older
* Provide signed written Informed Consent
* symptomatic AF documented by EKG or heart rhythm monitoring within 12 months
* patients should be on optimal medical therapy for heart failure for 3 months prior to randomization. Adjustments to medications within this 3 month period are permitted.
* chronically impaired LV function defined as EF between 20%-45% within last 3 months
* all patients should be on an optimal therapy for impaired LV function
* ability to complete 6 minute walk test
* eligible for catheter ablation and anti-arrhythmic drugs

Exclusion Criteria

* women of childbearing potential unless post- menopausal or surgically sterile
* patients hospitalized for heart failure within the 3 months prior to randomization
* reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma
* recent reversible LV impairment that may be attributed to AF with rapid ventricular response and may improve with introduction of rate control
* valvular heart disease requiring surgical intervention
* Coronary Artery Disease (CAD) requiring surgical or percutaneous intervention
* early post-operative AF (within 3 months of surgery)
* previous MAZE or left atrial instrumentation (including ablation and left atrial appendage exclusion)
* history of Atrioventricular Node (AVN) ablation
* hypertrophic cardiomyopathy
* prolonged QT interval
* liver failure
* renal failure requiring dialysis
* social factors that would preclude follow up or make compliance difficult- history of drug, alcohol or substance abuse
* contraindications to the use of AADs and/or anticoagulation therapy
* Currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* severe pulmonary disease
* documented intra-atrial thrombus, tumor, or structural abnormality which precludes catheter introduction
* unwilling to comply with protocol requirements or deemed by the investigator to be unfit for the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No