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RECRUITING
NCT03546374
NA

Medtronic Terminate AF Study

Sponsor: Medtronic Cardiac Surgery

View on ClinicalTrials.gov

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 atrial fibrillation (AF).

Official title: Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2018-11-15

Completion Date

2026-12

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

PROCEDURE

Surgical Ablation

In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.

DEVICE

Cardioblate and Cryoflex hand held devices

The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.

Locations (15)

Stanford Hospitals and Clinic

Palo Alto, California, United States

Adventist Health St. Helena

St. Helena, California, United States

Hartford Healthcare

Hartford, Connecticut, United States

St Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Corewell Health

Grand Rapids, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

ProMedica Toledo

Toledo, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Intermountain Medical Center

Murray, Utah, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Virginia Mason Heart Institute

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

St. Joseph Medical Center

Tacoma, Washington, United States