First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment
Who is this study for? Patients with persistent atrial fibrillation
What treatments are being studied? Radio Frequency Catheter Ablation
Status: Completed
Location: See all (5) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to determine if catheter-based atrial fibrillation (AF) ablation is superior to treatment with antiarrhythmic drugs as a first-line therapy for symptomatic persistent AF.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Eligible patients have a history of persistent AF with at least 2 episodes in the 9 months prior to enrollment. Persistent AF is defined according to 2014 AHA/ACC/HRS guidelines as continuous AF that is sustained for more than 7 days.Patients are enrolled if they are:
• Older than 18.
• Symptomatic with persistent AF.
• Experienced at least one AF episode that was documented by surface ECG, 6 months before randomization.
Locations
United States
Arizona
University of Arizona
Tucson
New York
Montefiore Medical Center
Bronx
Ohio
MetroHealth
Cleveland
Pennsylvania
Penn Presbyterian Medical Center
Philadelphia
University of Pennsylvania
Philadelphia
Time Frame
Start Date: 2019-09-24
Completion Date: 2024-10-01
Participants
Target number of participants: 25
Treatments
Active_comparator: Antiarrhythmic Medications
Patients randomized to the antiarrhythmic drug group are administered medications approved for treatment of AF by the regulatory bodies of each participating country. The selection of antiarrhythmic drugs and dosages is left to the discretion of the investigator, and will follow the AHA/ACC/HRS general guidelines
Active_comparator: Radio Frequency Catheter Ablation
Patients randomized to radiofrequency catheter ablation will undergo isolation of the pulmonary veins with confirmation of entrance block into each vein. The CARTO TM(Biosense Webster, CA) system will be used to reconstruct the atrial geometry and assist for mapping and ablation. Ablation will be performed using approved ablation devices (Biosense Webster, CA).
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: Texas Cardiac Arrhythmia Research Foundation, Biosense Webster, Inc.