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Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

Name: Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation — clinical trial record (NCT05115214)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: SpherePVI

StatusRecruiting

PhaseNot applicable

SponsorMedtronic Cardiac Ablation Solutions

Started2021-10-19

View on ClinicalTrials.gov ↗

A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.

Amendment history 2 changes detected by DataLookout

2026-09-16

Primary completion pushed: 2027-03-15 → 2029-09-15

2026-09-16

Completion pushed: 2027-10-15 → 2030-01-15

Trial Details

NCT Number	NCT05115214
Lead Sponsor	Medtronic Cardiac Ablation Solutions
Conditions	Atrial Fibrillation
Enrollment	150 participants
Start Date	2021-10-19
Primary Completion	2029-09-15 (estimated)
Study Completion	2030-01-15 (estimated)
Updated on ClinicalTrials.gov	2026-09-15