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RECRUITING
NCT07308847
NA

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

Sponsor: Medtronic Cardiac Ablation Solutions

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-01-15

Completion Date

2027-11-22

Last Updated

2026-04-08

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Sphere-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 (10)

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

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