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

Recruiting now · Not applicable

Conditions studied: Paroxysmal AF

In brief

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.

Key facts

Study ID

NCT07308847

Run by

Medtronic Cardiac Ablation Solutions

People needed

300

Starts

2026-01-15

Expected to finish

2027-11-22

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
• at least 1 electrocardiographically documented episode within 12 months prior to enrollment
• Adults who are ≥18 and ≤80 years of age on the day of enrollment.
• Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

You may not qualify if…

• 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
• AF that required three (3) or more distinct cardioversions in the preceding 12 months.
• LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)
• 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
• 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
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
• 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)
• Presence of any pulmonary vein stents
• Known pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
• Moderate to severe aortic or mitral valve stenosis
• Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
• Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
• Unstable angina
• 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)
• Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen
• Rheumatic heart disease
• Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
• Contraindication to or unwillingness to use systemic anticoagulation
• Documented left atrial thrombus on imaging
• Active systemic infection or sepsis
• Hypertrophic cardiomyopathy
• Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date

Where it is running

• Arrhythmia Research Group — Jonesboro, Arkansas, United States (enrolling)
• Scripps Memorial Hospital — La Jolla, California, United States (enrolling)
• Mercy General Hospital — Sacramento, California, United States (enrolling)
• NCH Rooney Heart Institute — Naples, Florida, United States (enrolling)
• Memorial Health University Medical Center — Savannah, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) — Overland Park, Kansas, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Southcoast Health System — Fall River, Massachusetts, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• The Valley Hospital — Paramus, New Jersey, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Northwell Health Lenox Hill Hospital — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)
• Bethesda North Hospital — Cincinnati, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Ohio Health Research and Innovation Institute — Columbus, Ohio, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States (enrolling)
• Inova Fairfax Hospital — Falls Church, Virginia, United States (enrolling)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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