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
Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-04-13
400
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the Sphere-9 Catheter and Affera Ablation System in adults with symptomatic recurrent paroxysmal or persistent atrial fibrillation who have previously undergone a single ablation procedure. This prospective, multi-center clinical study aims to assess the safety and effectiveness of this specific device-based redo ablation treatment in patients experiencing recurring atrial fibrillation symptoms. The study is conducted across up to 30 sites in the United States, Europe, and Australia, enrolling up to 400 participants. All participants will undergo a redo atrial fibrillation ablation procedure using the Sphere-9 Catheter along with the Affera Ablation and Mapping Systems. This intervention delivers radiofrequency and pulsed field energy according to the study protocol and is performed as a single-arm treatment with no comparison group. After the ablation procedure and hospital discharge, participants will be followed for 12 months with scheduled visits at 7 days, 3 months, 6 months, and 12 months post-procedure. The total study duration is approximately two years, including enrollment and follow-up periods. During the study, participants will be monitored for treatment success at 12 months and safety events at 6 months following the redo ablation. Assessments include clinical evaluations and a 24-hour Holter monitor at the final visit. Researchers will collect data on symptoms, recurrence of atrial fibrillation, and any adverse events. Participants will be exited from the study after completing the 12-month follow-up. No replacement of subjects will occur if early exit happens.
CONDITIONS
Brief 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 before enrollment
- Documented symptomatic recurrence of AF, atrial tachycardia, or atrial flutter at least 90 days after the prior ablation
- Evidence of at least 1 symptomatic AF, AT, or AFL episode within 12 months prior to enrollment confirmed by physician note and ECG
- Adults aged 18 years or older at enrollment
- Willing and able to comply with 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 for persistent AF or greater than 50 mm for paroxysmal AF, or corresponding volume thresholds
- Previous left atrial interventions like appendage occlusion or septal closure devices
- Planned left atrial appendage closure, cardiac transplant, or implant of certain pacemakers or defibrillators during follow-up
- More than one previous AF ablation or any prior surgical ablation
- Not on oral anticoagulation therapy for at least 3 weeks before ablation or contraindicated to anticoagulation
- Severe bleeding or clotting disorders
- Presence of pacemakers, implantable cardiac monitors, pulmonary vein stents, or other specific cardiac devices
- 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
- Advanced heart failure (NYHA Class III or IV) or low left ventricular ejection fraction (≤40%)
- Unstable angina or severe lung disease requiring oxygen
- Rheumatic heart disease or significant lung conditions
- Left atrial thrombus or active systemic infection
- Certain heart muscle diseases or tumors
- Known reversible causes of AF like uncontrolled hyperthyroidism or severe sleep apnea
- Recent strokes, carotid surgeries, or thromboembolic events within 6 months
- Body mass index over 40
- Pregnancy, breastfeeding, or unreliable birth control in women of childbearing potential
- Life expectancy less than 12 months
- Participation in other clinical studies without approval
- Severe kidney impairment or history of dialysis
- Vascular access or catheter introduction issues
- Drug or alcohol dependency
- Any significant medical problem that may affect study participation or data integrity as judged by the investigator
- Women of childbearing potential must have a pregnancy test before procedure according to local rules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a redo atrial fibrillation ablation procedure using the Sphere-9 Catheter and Affera Ablation System.
1 procedure visit (in-person)
Duration - 12 months
Participants are followed after the ablation procedure to monitor safety and effectiveness, including hospital discharge and scheduled follow-up visits.
Visits at 7 days, 3 months, 6 months, and 12 months post-procedure
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
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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