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RECRUITING
NCT06858306

SPHERE Per-AF Post-Approval Study

Sponsor: Medtronic Cardiac Ablation Solutions

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-09-25

Completion Date

2030-10

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DEVICE

Sphere-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