NCT06393920

PulseSelect™ PFA Global Registry

PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,950 (estimated)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2024-07-23
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2024-05-01
• Last updated: 2026-02-06

Locations

28 sites across 10 countries: Canada, China, France, Germany, Greece, Italy, Netherlands, South Korea, Spain, United Kingdom