NCT03546374 · Medtronic Cardiac Surgery
Medtronic Terminate AF Study
What this study is about
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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
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
Where
- Palo Alto, California
- St. Helena, California
- Hartford, Connecticut
- Indianapolis, Indiana
- Boston, Massachusetts
- Grand Rapids, Michigan
- St Louis, Missouri
- Toledo, Ohio
- Pittsburgh, Pennsylvania
- Wynnewood, Pennsylvania
- Murray, Utah
- Norfolk, Virginia
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations