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RECRUITING
NCT05115214
NA

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

Sponsor: Medtronic Cardiac Ablation Solutions

View on ClinicalTrials.gov

Summary

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.

Official title: A Safety and Performance Assessment of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-10-19

Completion Date

2027-10-15

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

DEVICE

SpherePVI™ Catheter

Affera SpherePVI™ Multi-Ablation System

Locations (2)

Homolka Hospital

Prague, Czechia

Institute Klinicke a Experimentalni Mediciny

Prague, Czechia