PulseSelect™ PFA Global Registry

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06393920
• Lead Sponsor: Medtronic Cardiac Ablation Solutions

Brief Summary

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.

Detailed Description

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Study Timeline

• Study First Submitted: 2024-04-28
• Study First Submitted QC: 2024-04-28
• Study First Posted: 2024-05-01
• Study Start: 2024-07-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subject is ≥ 18 years of age or minimum age as required by local regulations.
• Subject has been diagnosed with atrial fibrillation (AF)
• Planned procedure using commercially available PulseSelect™ PFA System.
• Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.

Exclusion Criteria

• Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
• Subject with exclusion criteria required by local law.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy-Freedom from Atrial Fibrillation	≥ 91 days after the index ablation procedure	Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
Safety- Freedom from Device/Procedure Related Adverse Events	Within 6 months post-ablation	Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system

Trial Locations

Locations (12)

Complejo Asistencial Universitario de Salamanca; 🇪🇸 Salamanca, Spain

St. Vincenz-Krankenhaus Paderborn; 🇩🇪 Paderborn, Germany

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

McGill University Health Centre (MUHC); 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Grenoble - Site Nord; 🇫🇷 Grenoble, France

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Asklepios Klinik St Georg; 🇩🇪 Hamburg, Germany

IRCCS Ospedale Sacro Cuore Don Calabria; 🇮🇹 Negrar Di Valpolicella, Verona, Italy

St Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Centralny Szpital Kliniczny Uniwersytetu Medyczneg; 🇵🇱 Lódź, Poland

Basildon and Thurrock University Hospitals; 🇬🇧 Basildon, United Kingdom

University Hospitals Coventry & Warwickshire; 🇬🇧 Coventry, United Kingdom