New device aims to tame stubborn atrial fibrillation after first ablation fails

NCT ID NCT07298473

Disease control Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests a new catheter system (Sphere-9) for a repeat heart ablation procedure in 400 people whose atrial fibrillation came back after an earlier ablation. The procedure uses radiofrequency and pulsed field energy to correct faulty heart signals. Participants will be followed for 12 months to see if the treatment safely controls their heart rhythm without needing more procedures or strong medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Sphere-9 Catheter and Affera Ablation System (device delivering radiofrequency and pulsed field energy)
What this could lead to: If successful, this could offer a more effective option for people whose atrial fibrillation returns after a first ablation, potentially reducing the need for further procedures or long-term medication.
What could go wrong: This is a non-randomized, single-arm study, so results may be less definitive. Risks include serious complications like stroke, heart block, or esophageal injury. Success depends on individual factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF) Paroxysmal atrial fibrillation (PAF) Persistent atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

30 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Adelaide University
RECRUITING

Adelaide, South Australia, 5000, Australia
AdventHealth Cardiovascular Research Institute
NOT_YET_RECRUITING

Orlando, Florida, 32803, United States
Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212-4756, United States
Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048-1804, United States
Centra Medical Group Stroobants Cardiovascular Center
RECRUITING

Lynchburg, Virginia, 24501, United States
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
Clinique Pasteur
NOT_YET_RECRUITING

Toulouse, 31076, France
Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
IKEM - Institut Klinické a Experimentální Medicíny
NOT_YET_RECRUITING

Prague, 140 21, Czechia
Inova Fairfax Hospital
RECRUITING

Falls Church, Virginia, 22042, United States
Inselspital - Universitätsspital Bern
NOT_YET_RECRUITING

Bern, 3010, Switzerland
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
NOT_YET_RECRUITING

Kansas City, Missouri, 64111, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114-2621, United States
Memorial Health University Medical Center
RECRUITING

Savannah, Georgia, 31404, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
Motol and Homolka University Hospital
NOT_YET_RECRUITING

Prague, 150 30, Czechia
NCH Rooney Heart Institute
RECRUITING

Naples, Florida, 34102, United States
NYU Langone Health
RECRUITING

New York, New York, 10016-4972, United States
Northwell Health Lenox Hill Hospital
RECRUITING

New Hyde Park, New York, 11040-1402, United States
OhioHealth Research and Innovation Institute (OHRI)
RECRUITING

Columbus, Ohio, 43214-3467, United States
Piedmont Heart Institute
RECRUITING

Atlanta, Georgia, 30309, United States
Scripps Green Hospital
NOT_YET_RECRUITING

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital
RECRUITING

Newport News, Virginia, 23606-2981, United States
Texas Cardiac Arrhythmia Research Foundation
RECRUITING

Dallas, Texas, 75226, United States
Texas Health Fort Worth
RECRUITING

Fort Worth, Texas, 76104, United States
The Royal Melbourne Hospital
RECRUITING

Parkville, Victoria, 3050, Australia
Universitair Ziekenhuis Brussel
NOT_YET_RECRUITING

Brussels, 1090, Belgium
University of Alabama at Birmingham (UAB) Hospital
RECRUITING

Birmingham, Alabama, 35233, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232-0019, United States
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia

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