Medtronic Terminate AF Study
Recruiting · NCT03546374 · Interventional (participants receive a specific treatment) · Lead sponsor: Medtronic Cardiac Surgery
View the official record on ClinicalTrials.gov →Interventions studied
Cardioblate and Cryoflex hand held devicesSurgical Ablation
What this trial 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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
15 locations listed across 11 US states.
- 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