Medtronic Terminate AF Study

Status Recruiting

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal AF.

Clinical Trial Description

This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the US. The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling. ;

Study Design

Related Conditions & MeSH terms

Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Persistent Atrial Fibrillation

Clinical Trial Details

NCT number	NCT03546374
Study type	Interventional
Source	Medtronic Cardiac Surgery
Contact	Stephanie Yong
Phone	763-526-2032
Email	stephanie.yong@medtronic.com
Status	Recruiting
Phase	N/A
Start date	November 15, 2018
Completion date	August 2024

View Details

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