SPHERE Per-AF Post-Approval Study

Last updated: May 6, 2026
Sponsor: Medtronic Cardiac Ablation Solutions
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chest Pain

Arrhythmia

Dysrhythmia

Treatment

Sphere-9™ Catheter and Affera™ Ablation System

Clinical Study ID

NCT06858306
SPHERE Per-AF PAS
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longerthan 7 days but less than 12 months)

  2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one ClassI or III antiarrhythmic drug (AAD)

  3. Patient is ≥ 18 years of age

  4. Planned de novo pulmonary vein isolation procedure using commercially availableSphere-9™ Catheter and Affera Ablation System

  5. Patient is willing and able to comply with study requirements and give informedconsent

Exclusion

Exclusion Criteria:

  1. Long-standing persistent AF (continuous AF sustained >12 months)

  2. Prior left atrial catheter or surgical ablation

  3. Life expectancy <36 months

  4. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertablecardiac monitor (ICM), or any type of implantable cardiac defibrillator (with orwithout biventricular pacing function)

  5. Current or anticipated participation in any other clinical trial of a drug, deviceor biologic during the duration of this study not pre-approved by Medtronic

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Sphere-9™ Catheter and Affera™ Ablation System
Phase:
Study Start date:
September 25, 2025
Estimated Completion Date:
October 31, 2030

Study Description

The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).

Connect with a study center

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama at Birmingham Hospital

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota 4172131, Florida 4155751 34239
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Site Not Available

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Montefiore Medical Center

    New York, New York 10467
    United States

    Site Not Available

  • Montefiore Medical Center

    New York 5128581, New York 5128638 10467
    United States

    Site Not Available

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28230
    United States

    Site Not Available

  • OhioHealth

    Columbus, Ohio 43214
    United States

    Site Not Available

  • OhioHealth

    Columbus 4509177, Ohio 5165418 43214
    United States

    Site Not Available

  • Doylestown Health Cardiology

    Doylestown, Pennsylvania 18901
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Doylestown Health Cardiology

    Doylestown 5187247, Pennsylvania 6254927 18901
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Texas Health Resources

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Health Resources

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Virginia Medical Center

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Centra Medical Group Stroobants Cardiovascular Center

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • University of Virginia Medical Center

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Centra Medical Group Stroobants Cardiovascular Center

    Lynchburg 4771075, Virginia 6254928 24501
    United States

    Site Not Available

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