Catheter Ablation vs. Medical Therapy in Congested Hearts With AF

• Status: Terminated
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oussama Wazni
• Collaborators: Biosense Webster, Inc.; The Cleveland Clinic
• Treatments: Anti-Arrhythmia Agents

Criteria

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.