Actively Recruiting
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)
Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-04-13
400
Participants Needed
30
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of a single atrial fibrillation ablation procedure for paroxysmal or persistent AF within 3 years prior to enrollment
- Documented symptomatic AF, atrial tachycardia, or atrial flutter recurrence at least 90 days after the original ablation
- Physician note indicating at least one symptomatic episode within 12 months before enrollment
- At least one electrocardiographically documented episode within 12 months before enrollment
- Adults aged 18 years or older on the day of enrollment
- Willing and able to follow all study requirements and provide informed consent
You will not qualify if you...
- Continuous atrial fibrillation lasting 12 months or longer
- Left atrial diameter greater than 55 mm (persistent AF) or 50 mm (paroxysmal AF), or specified volume limits if diameter not available
- Previous left atrial interventions including appendage occlusion or septal closure devices
- Planned left atrial appendage closure, cardiac transplant, or implant of pacemaker, defibrillator, or cardiac monitor during follow-up
- More than one previous AF ablation procedure or any prior surgical ablation
- Not on oral anticoagulation therapy for at least 3 weeks before ablation
- Contraindication to or unwillingness to use systemic anticoagulation
- Severe bleeding or clotting disorders
- Presence of pacemakers, defibrillators, or pulmonary vein stents
- Known pulmonary vein stenosis or hemidiaphragmatic paralysis
- Prior valvular procedures or moderate to severe valve disease
- Recent cardiac surgery, heart attack, or coronary procedures within 3 months
- NYHA Class III or IV heart failure
- Left ventricular ejection fraction 40% or less
- Unstable angina
- Severe lung disease or pulmonary hypertension requiring oxygen
- Rheumatic heart disease or significant lung disease
- Left atrial thrombus or active infection
- Hypertrophic cardiomyopathy, amyloid heart disease, or atrial myxoma
- Reversible causes of AF like uncontrolled hyperthyroidism or severe sleep apnea
- Stroke or TIA within past 6 months
- Carotid stenting or endarterectomy
- Recent thromboembolic event or intracardiac thrombus
- Body mass index over 40 kg/m2
- Pregnancy, breastfeeding, or unreliable contraception
- Life expectancy unlikely to complete 12 months follow-up
- Participation in other unapproved clinical studies
- Severe kidney failure or dialysis
- Vascular access abnormalities or inferior vena cava filters
- Known drug or alcohol dependency
- Significant congenital or medical problems that affect study participation or integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Scripps Green Hospital
La Jolla, California, United States, 92037
Not Yet Recruiting
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048-1804
Not Yet Recruiting
4
NCH Rooney Heart Institute
Naples, Florida, United States, 34102
Actively Recruiting
5
AdventHealth Cardiovascular Research Institute
Orlando, Florida, United States, 32803
Not Yet Recruiting
6
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Not Yet Recruiting
7
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Not Yet Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2621
Actively Recruiting
9
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
Kansas City, Missouri, United States, 64111
Not Yet Recruiting
10
Northwell Health Lenox Hill Hospital
New Hyde Park, New York, United States, 11040-1402
Not Yet Recruiting
11
NYU Langone Medical Center
New York, New York, United States, 10016-4972
Not Yet Recruiting
12
Montefiore Medical Center
The Bronx, New York, United States, 10467
Not Yet Recruiting
13
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
14
OhioHealth Research and Innovation Institute (OHRI)
Columbus, Ohio, United States, 43214-3467
Not Yet Recruiting
15
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
16
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4756
Not Yet Recruiting
17
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-0019
Not Yet Recruiting
18
Texas Cardiac Arrhythmia Research Foundation
Dallas, Texas, United States, 75226
Actively Recruiting
19
Texas Health Fort Worth
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
20
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
21
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, United States, 24501
Not Yet Recruiting
22
Sentara Norfolk General Hospital
Newport News, Virginia, United States, 23606-2981
Not Yet Recruiting
23
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
24
Adelaide University
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
25
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
26
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Not Yet Recruiting
27
IKEM - Institut Klinické a Experimentální Medicíny
Prague, Czechia, 140 21
Not Yet Recruiting
28
Motol and Homolka University Hospital
Prague, Czechia, 150 30
Not Yet Recruiting
29
Clinique Pasteur
Toulouse, France, 31076
Not Yet Recruiting
30
Inselspital - Universitätsspital Bern
Bern, Switzerland, 3010
Not Yet Recruiting
Research Team
R
Ryan S Radtke, Bachelors of Science- Biology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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