Active — Not RecruitingNot Applicable

SPHERE Per-AF Post-Approval Study

United States200 participantsStarted 2025-09-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
✓. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
✓. Patient is ≥ 18 years of age
✓. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
✓. Patient is willing and able to comply with study requirements and give informed consent

Exclusion criteria

✕. Long-standing persistent AF (continuous AF sustained \>12 months)
✕. Prior left atrial catheter or surgical ablation
✕. Life expectancy \<36 months
✕. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
✕. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic

What they're measuring

Primary Safety Objective

Timeframe: Through 180 days Post-Procedure

Primary Effectiveness Objective

Timeframe: Through 36 months Post-Procedure

Trial details

NCT IDNCT06858306

SponsorMedtronic Cardiac Ablation Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-10

View on ClinicalTrials.gov More Persistent Atrial Fibrillation trials