RECRUITING Not applicable ClinicalTrials.gov

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)

Sponsor: Medtronic Cardiac Ablation Solutions • ClinicalTrials.gov ID: NCT07298473

Registry updated: 2026-10-19

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Sphere-9 Catheter Ablation (Device)
Redo atrial fibrillation ablation performed using the Sphere-9 Catheter in conjunction with the Affera Ablation System and Affera Mapping System. The intervention delivers radiofrequency and pulsed field energy according to the study protocol for treatment of recurrent paroxysmal or persistent AF. All participants receive this device-based ablation procedure.

Eligibility criteria

Inclusion Criteria: * 1\. History of a single AF ablation procedure for PAF or PsAF within 3 years prior to enrollment 2. Documented evidence of symptomatic AF, AT or AFL recurrence at least 90 days after subject's de novo ablation procedure, as demonstrated by: * A physicians' note indicating at least 1 symptomatic AF, AT, or AFL episode occurring within 12 months prior to the enrollment; and * At least 1 electrocardiographically documented episode of AF, AT, or AFL within 12 months prior to enrollment 3. Adults who are ≥18 years of age on the day of enrollment 4. Willing and able to comply with all study requirements and provide informed consent Exclusion Criteria: * 1\. Continuous AF lasting for 12 months or longer 2. LA anteroposterior \>55 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \>100 mL for PsAF subjects; OR LA anteroposterior \>50 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \>95 mL for PAF subjects 3. Previous left atrial percutaneous interventions including left atrial appendage occlusion and septal closure devices 4. Planned left atrial appendage (LAA) closure procedure, cardiac transplantation or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period 5. More than 1 previous AF ablation procedure 6. Any prior surgical ablation procedure 7. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure 8. Contraindication to or unwillingness to use systemic anticoagulation 9. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder 10. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 11. Presence of any pulmonary vein stents 12. Known pre-existing pulmonary vein stenosis 13. Pre-existing hemidiaphragmatic paralysis 14. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, or any prior atriotomy 15. Moderate to severe mitral valve or aortic stenosis 16. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR) 17. Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months preceding the consent date 18. NYHA Class III or IV congestive heart failure 19. Documented left ventricular ejection fraction (LVEF) ≤40%, measured by acceptable cardiac testing (e.g., TTE) 20. Unstable angina 21. Severe lung disease, primary pulmonary hypertension, or any lung disease requiring supplemental oxygen 22. Rheumatic heart disease 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition 24. Presence of left atrial thrombus on imaging 25. Active systemic infection or sepsis 26. Hypertrophic cardiomyopathy 27. Amyloid heart disease 28. Diagnosed atrial myxoma 29. Known reversible causes of AF (e.g., uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, acute alcohol toxicity or other reversible or non-cardiac cause) 30. Any cerebral ischemic event (strokes or TIAs) which occurred within the preceding 6 months of the consent date through the date of study index redo ablation procedure 31. Carotid stenting or endarterectomy 32. Thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure 33. Body mass index \> 40 kg/m2 34. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\* 35. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed 36. Current or anticipated participation in any other clinical study of a drug, device or biologic during the duration of the study not pre-approved by Medtronic 37. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant 38. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation 39. Presence of an inferior vena cava (IVC) filter (e.g., Greenfield or similar) that would preclude safe transfemoral venous access, catheter passage, or sheath manipulation. 40\. Known drug or alcohol dependency 41. Significant congenital anomaly or medical problem that would, in the opinion of the investigator, preclude enrollment, follow-up compliance, or the scientific integrity of the study \*Women who are of child-bearing potential must undergo a pregnancy test after consent and prior to the study index redo ablation procedure, as allowed according to local regulations

Conditions

Atrial Fibrillation (AF) Persistent Atrial Fibrillation Paroxysmal Atrial Fibrillation (PAF)

Locations

University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
Scripps Green Hospital — La Jolla, California, United States
Cedars Sinai Medical Center — Los Angeles, California, United States
NCH Rooney Heart Institute — Naples, Florida, United States
AdventHealth Cardiovascular Research Institute — Orlando, Florida, United States
Piedmont Heart Institute — Atlanta, Georgia, United States
Memorial Health University Medical Center — Savannah, Georgia, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) — Kansas City, Missouri, United States
Northwell Health Lenox Hill Hospital — New Hyde Park, New York, United States
NYU Langone Health — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute (OHRI) — Columbus, Ohio, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation — Dallas, Texas, United States
Texas Health Fort Worth — Fort Worth, Texas, United States
Inova Fairfax Hospital — Falls Church, Virginia, United States
Centra Medical Group Stroobants Cardiovascular Center — Lynchburg, Virginia, United States
Sentara Norfolk General Hospital — Newport News, Virginia, United States
Westmead Hospital — Westmead, New South Wales, Australia
Adelaide University — Adelaide, South Australia, Australia
The Royal Melbourne Hospital — Parkville, Victoria, Australia
Universitair Ziekenhuis Brussel — Brussels, Belgium
IKEM - Institut Klinické a Experimentální Medicíny — Prague, Czechia
Motol and Homolka University Hospital — Prague, Czechia
Clinique Pasteur — Toulouse, France
Inselspital - Universitätsspital Bern — Bern, Switzerland

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment