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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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.
Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines
Hartford Hospital
Hartford, Connecticut, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion
Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed).
Time frame: 12 months
Total Number of Cardiovascular Hospitalization
total number of cardiovascular hospitalization measured by hospitalization admissions
Time frame: 15 months
Time to Recurrence if AF Lasting Longer Than 30 Seconds
time measured in days to recurrence of AF lasting longer than 30 seconds
Time frame: 15 months
Distance Walked in a 6-mile Walk Test
change in distance walked in 6 mile walk test
Time frame: 3 months through 15 months
Change in the Rand 36-Item Health Survey
change in the Rand 36-Item Health Survey reflective of change in patient's quality of life
Time frame: 3 months through 15 months
Change in Ejection Fraction (EF)
Change in Ejection Fraction heart failure measurement (percentage)
Time frame: baseline through15 months
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States