NCT04198701

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Medtronic PulseSelect Pulsed Field Ablation (PFA) System	Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.

Timeline

• Start date: 2019-12-10
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2019-12-13
• Last updated: 2025-02-13
• Results posted: 2023-12-13

Locations

41 sites across 9 countries: United States, Australia, Austria, Belgium, Canada, France, Japan, Netherlands, Spain

Regulatory

• FDA-regulated device study