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NCT03546374NARecruiting

Medtronic Terminate AF Study

Medtronic Cardiac Surgery

Start Date

11/15/2018

Completion Date

12/1/2026

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).

Detailed 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 United States (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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * History of non-paroxysmal AF (persistent or longstanding persistent) * Concomitant indication for non-emergent open-heart surgery, eg, 1. Coronary artery bypass grafting 2. Valve repair or replacement * Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC) Exclusion Criteria: * Wolff-Parkinson-White syndrome * New York Heart Association (NYHA) Class = IV * Left Ventricular Ejection Fraction ≤ 30% * Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery * Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure * Contraindication for anticoagulation therapy * Left atrial diameter \> 6.0 cm * Preoperative need for an intra-aortic balloon pump or intravenous inotropes * Renal failure requiring dialysis or hepatic failure * Life expectancy of less than 1 year * Predicted risk of operative mortality \>10% as assessed by STS Risk Calculator * Pregnancy or desire to be pregnant within 12 months of the study treatment * Current diagnosis of active systemic infection * Active endocarditis * Documented MI 30 days prior to study enrollment * Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias

Interventions

PROCEDURE

Surgical Ablation

DEVICE

Cardioblate and Cryoflex hand held devices

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Conditions

Persistent Atrial FibrillationLongstanding Persistent Atrial Fibrillation

Locations

Stanford Hospitals and Clinic

Palo Alto, California 94304

United States

Adventist Health St. Helena

St. Helena, California 94574

United States

Hartford Healthcare

Hartford, Connecticut 06102

United States

St Vincent Heart Center of Indiana

Indianapolis, Indiana 46290

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

ProMedica Toledo

Toledo, Ohio 43606

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

Lankenau Medical Center

Wynnewood, Pennsylvania 19096

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

Virginia Mason Heart Institute

Seattle, Washington 98101

United States

Swedish Medical Center

Seattle, Washington 98122

United States

St. Joseph Medical Center

Tacoma, Washington 98405

United States