RecruitingNot ApplicableNCT07308847

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

Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Prospective, Single Arm, Unblinded Pre-market Clinical Study to Evaluate the Safety and Effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for Treating Paroxysmal Atrial Fibrillation (PAF)


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

300 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new catheter-based heart procedure using the Sphere-360 catheter and Affera mapping system to treat paroxysmal atrial fibrillation (PAF) — a type of irregular heartbeat that comes and goes — by creating precise ablation (scar tissue) in the heart to block the abnormal electrical signals. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with recurrent symptomatic paroxysmal atrial fibrillation (PAF), with at least 2 symptomatic episodes in the past 6 months and at least one confirmed on an ECG in the past 12 months - Each AF episode lasts more than 30 seconds but stops on its own or with treatment within 7 days - You are willing and able to complete all follow-up visits **You may NOT be eligible if...** - You have persistent or permanent atrial fibrillation (where it does not stop on its own) - You have had previous ablation for AF - You have other significant heart conditions or structural heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Pulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System


Locations(12)

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Southcoast Health System

Fall River, Massachusetts, United States

The Valley Hospital

Paramus, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Northwell Health Lenox Hill Hospital

New York, New York, United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT07308847


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