RecruitingNCT06858306

SPHERE Per-AF Post-Approval Study

SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

200 participants

Start Date

Sep 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This post-approval study is monitoring the real-world safety and effectiveness of the Sphere-9 catheter and Affera ablation system for treating persistent atrial fibrillation (AF) — a type of irregular heartbeat — using a procedure called pulmonary vein isolation. **You may be eligible if...** - You are 18 or older - You have recurrent symptomatic persistent AF (AF lasting more than 7 days but less than 12 months) - Your AF has not responded to, was not tolerated by, or you did not want at least one anti-arrhythmic drug - Your doctor is planning to perform a new (de novo) pulmonary vein isolation using the Sphere-9 catheter system **You may NOT be eligible if...** - You have long-standing persistent AF (lasting more than 12 months) - You have had a prior heart ablation procedure in the left atrium - You have a pacemaker, defibrillator, or similar cardiac implant - Your life expectancy is less than 36 months 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-9™ Catheter and Affera™ Ablation System

De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System


Locations(14)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Montefiore Medical Center

New York, New York, United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

OhioHealth

Columbus, Ohio, United States

Doylestown Health Cardiology

Doylestown, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Texas Health Resources

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Centra Medical Group Stroobants Cardiovascular Center

Lynchburg, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06858306


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