Medtronic Terminate AF Study

Recruiting now · Not applicable

Conditions studied: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

In brief

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).

Key facts

Study ID

NCT03546374

Run by

Medtronic Cardiac Surgery

People needed

160

Starts

2018-11-15

Expected to finish

2026-12-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of non-paroxysmal AF (persistent or longstanding persistent)
• Concomitant indication for non-emergent open-heart surgery, eg,
• Coronary artery bypass grafting
• Valve repair or replacement
• Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)

You may not qualify if…

• 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

Where it is running

• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Corewell Health — Grand Rapids, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Virginia Mason Heart Institute — Seattle, Washington, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• St Vincent Heart Center of Indiana — Indianapolis, Indiana, United States (enrolling)
• Stanford Hospitals and Clinic — Palo Alto, California, United States
• St. Joseph Medical Center — Tacoma, Washington, United States
• Adventist Health St. Helena — St. Helena, California, United States
• Hartford Healthcare — Hartford, Connecticut, United States
• ProMedica Toledo — Toledo, Ohio, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Intermountain Medical Center — Murray, Utah, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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