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Conquer-AF Study for Recurrent Atrial Fibrillation

This study, called Conquer-AF, is looking at a new way to treat recurrent atrial fibrillation (AF), which is an irregular and often rapid heart rhythm. It's for people who have already had one AF ablation procedure (a treatment to correct the heart's rhythm) but are still experiencing symptoms. The study is testing the safety and effectiveness of a specific treatment called the Sphere-9 Catheter and Affera Ablation System. This system uses both radiofrequency and pulsed field energy to treat your heart. Researchers will measure how many participants have successful treatment after 12 months and track any safety events for 6 months. The study aims to enroll up to 400 people across the United States, Europe, and Australia. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is not randomized, and it plans to enroll up to 400 participants.
What's involved
You would undergo a redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System. You would then have follow-up visits at 7 days, 3 months, 6 months, and 12 months after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their redo ablation procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07298473

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)

Recruiting
NAAges 18+InterventionalTreatment
Medtronic Cardiac Ablation Solutions
~400 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Sphere-9 Catheter Ablation

At a glance

Recruiting sites
22 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness: Number of Participants With Treatment Success.
Measured over 12-months post-redo ablation procedure
+1 more outcome measured

Conditions

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

Explore related trials

Atrial Fibrillation

NCT07298473

Where you'd take part

This study runs at 30 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Adelaide University

    Adelaide, South Australia, Australiastudy coordinator listed

    Recruiting

  • AdventHealth Cardiovascular Research Institute

    Orlando, Floridastudy coordinator listed

    Not yet recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Centra Medical Group Stroobants Cardiovascular Center

    Lynchburg, Virginiastudy coordinator listed

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohiostudy coordinator listed

    Recruiting

  • Clinique Pasteur

    Toulouse, Francestudy coordinator listed

    Not yet recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Khaldoun Tarakji, MD · STUDY_DIRECTOR · Medtronic

Who to contact

Ryan S Radtke, Bachelors of Science- Biology
[email protected]
712-941-9372
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Effectiveness: Number of Participants With Treatment Success.12-months post-redo ablation procedure

    Treatment success is defined to be freedom from treatment failure. The study requires 24-hour Holter monitoring at 6 and 12 months, weekly and symptomatic patient activated TTM transmissions through 12 months, and 12-lead ECGs or TTMs at all follow up visits. Treatment failure is defined as any of the following components: * Inability to successfully complete the study index redo ablation procedure utilizing the Sphere-9 Catheter and Affera Ablation System exclusively * Documented AF/AT/AFL after the 90-day post-ablation blanking period * Any subsequent catheter or surgical ablation, for recurrent AF/AT/AFL including repeat redo ablation at any time during the study * Direct current or pharmacological cardioversion for AF/AT/AFL recurrences after the 90-day blanking period (See section 9.11) * Use of a Class I or III AAD at a higher daily dose than the pre-ablation maximum dose after the 90-day blanking period and on or before day 365. * Initiation of a new Class I or III AAD after t

  • Safety: Number of Participants With at Least One Primary Safety Event6-months post-redo ablation procedure

    Primary safety events include: * 7 days of post-ablation: AKI requiring dialysis, new hospitalization \>48 hours, or prolongation of hospitalization \>48 hours beyond expected discharge, Death, Heart block requiring pacemaker, Major bleeding requiring transfusion, MI, Permanent phrenic nerve paralysis, Pulmonary edema, Severe pericarditis, Significant pericardial effusion/tamponade, Stroke/CVA, Systemic/pulmonary embolism requiring intervention, TIA, Vagal nerve injury resulting in esophageal dysmotility or gastroparesis, Vascular access complications requiring intervention, Any Sphere-9 Catheter or Affera Mapping \& Ablation System device- or procedure-related cardiovascular and/or pulmonary AE that prolongs or requires hospitalization \>48 hours (excl recurrent AF/AT/AFL) * 3 months post-ablation: Atrioesophageal fistula/esophago-pericardial fistula, Esophageal perforation (procedure \& Sphere-9 Catheter related) * 6 months post-ablation: Pulmonary vein stenosis (≥70% diameter reduction)