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NCT07308847NARecruiting

Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Medtronic Cardiac Ablation Solutions

Start Date

1/15/2026

Completion Date

11/22/2027

Summary

The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.

Eligibility Criteria

Age Range: 18 years to 80 years

Inclusion Criteria: 1. A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following: 1. a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and 2. at least 1 electrocardiographically documented episode within 12 months prior to enrollment 2. Adults who are ≥18 and ≤80 years of age on the day of enrollment. 3. Willing and able to comply with all baseline and follow-up evaluations for the full length of the study. Exclusion Criteria: 1. Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration \> 7 days 2. AF that required three (3) or more distinct cardioversions in the preceding 12 months. 3. LA anteroposterior \> 5.0 cm (by MRI, CT, or TTE) 4. Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices 5. Planned LAA closure procedure 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 6. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure 7. 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) 8. Presence of any pulmonary vein stents 9. Known pre-existing pulmonary vein stenosis 10. Pre-existing hemidiaphragmatic paralysis 11. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy 12. Moderate to severe aortic or mitral valve stenosis 13. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR) 14. Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date 15. Unstable angina 16. NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD) 17. Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen 18. Rheumatic heart disease 19. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder 20. Contraindication to or unwillingness to use systemic anticoagulation 21. Documented left atrial thrombus on imaging 22. Active systemic infection or sepsis 23. Hypertrophic cardiomyopathy 24. Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity 25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date 26. Carotid stenting or endarterectomy 27. History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure 28. 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 29. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed 30. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic 31. Known allergies or hypersensitivities to adhesives 32. Body mass index \> 40 kg/m2 33. Atrial myxoma 34. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 35. 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 36. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant 37. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation 38. Known drug or alcohol dependency 39. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results. 40. Treatment with Amiodarone within the 3 months prior to enrollment 41. Amyloid heart disease (cardiac amyloidosis)

Interventions

DEVICE

Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System

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Conditions

Paroxysmal AF

Locations

Arrhythmia Research Group

Jonesboro, Arkansas 72401

United States

Scripps Memorial Hospital

La Jolla, California 92037

United States

Mercy General Hospital

Sacramento, California 95819

United States

NCH Rooney Heart Institute

Naples, Florida 34102

United States

Memorial Health University Medical Center

Savannah, Georgia 31404

United States

Northwestern University

Chicago, Illinois 60611

United States

Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)

Overland Park, Kansas 66211

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Southcoast Health System

Fall River, Massachusetts 02720

United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota 55407

United States

Mayo Clinic

Rochester, Minnesota 55902

United States

The Valley Hospital

Paramus, New Jersey 07652

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Northwell Health Lenox Hill Hospital

New York, New York 10075

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

Bethesda North Hospital

Cincinnati, Ohio 45220

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Ohio Health Research and Innovation Institute

Columbus, Ohio 43214-3907

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas 78705

United States

Inova Fairfax Hospital

Falls Church, Virginia 22042

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States