Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)
Start Date
4/8/2026
Completion Date
3/29/2028
Summary
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia. Subjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.
Detailed Description
The Conquer-AF study is a prospective, multi-center, interventional, non-randomized clinical study to evaluate the safety and effectiveness of the Sphere-9 Catheter and Affera Ablation System, when used in conjunction with the Affera Mapping System or Affera Integrated Mapping System, in patients undergoing redo ablation for symptomatic recurrent paroxysmal or persistent atrial fibrillation following a single prior ablation procedure. This study will enroll up to 400 subjects diagnosed with symptomatic recurrent PAF and PsAF and will be conducted at up to 30 study sites located across the United States, Europe, and Australia. No single site may enroll more than 60 (with no more than 37 in either cohort) subjects to ensure a reasonable distribution of subjects across sites. Adult subjects with symptomatic recurrent PAF and PsAF will undergo a study index redo ablation procedure with the Sphere-9 Catheter and Affera Ablation System. Following the study index redo ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 3 months, 6 months, and 12 months post-procedure. Subjects will be exited from the study at the conclusion of the 12-month follow-up visit and associated 24-hour Holter. The expected total study duration is approximately 2 years, representing approximately 12 months of enrollment and 12 months of subject follow-up. Treated subjects will not be replaced with newly enrolled subjects upon early study exit.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Sphere-9 Catheter Ablation
Conditions
Locations
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama 35233
United States
Scripps Green Hospital
La Jolla, California 92037
United States
Cedars Sinai Medical Center
Los Angeles, California 90048-1804
United States
NCH Rooney Heart Institute
Naples, Florida 34102
United States
AdventHealth Cardiovascular Research Institute
Orlando, Florida 32803
United States
Piedmont Heart Institute
Atlanta, Georgia 30309
United States
Memorial Health University Medical Center
Savannah, Georgia 31404
United States
Massachusetts General Hospital
Boston, Massachusetts 02114-2621
United States
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Kansas City, Missouri 64111
United States
Northwell Health Lenox Hill Hospital
New Hyde Park, New York 11040-1402
United States
NYU Langone Health
New York, New York 10016-4972
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
OhioHealth Research and Innovation Institute (OHRI)
Columbus, Ohio 43214-3467
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212-4756
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232-0019
United States
Texas Cardiac Arrhythmia Research Foundation
Dallas, Texas 75226
United States
Texas Health Fort Worth
Fort Worth, Texas 76104
United States
Inova Fairfax Hospital
Falls Church, Virginia 22042
United States
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia 24501
United States
Sentara Norfolk General Hospital
Newport News, Virginia 23606-2981
United States
Westmead Hospital
Westmead, New South Wales 2145
Australia
Adelaide University
Adelaide, South Australia 5000
Australia
The Royal Melbourne Hospital
Parkville, Victoria 3050
Australia
Universitair Ziekenhuis Brussel
Brussels, 1090
Belgium
IKEM - Institut Klinické a Experimentální Medicíny
Prague, 140 21
Czechia
Motol and Homolka University Hospital
Prague, 150 30
Czechia
Clinique Pasteur
Toulouse, 31076
France
Inselspital - Universitätsspital Bern
Bern, 3010
Switzerland