Treatment of persistent atrial fibrillation using specialized devices during heart surgery
Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
This study tests if special devices used during heart surgery can safely help people with persistent atrial fibrillation feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Cardiac Surgery Industry-sponsored |
| Locations | 15 sites (Palo Alto, California and 14 other locations) |
| Trial ID | NCT03546374 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the Cardioblate iRF and CryoFlex handheld devices for treating non-paroxysmal atrial fibrillation in patients undergoing cardiac surgery. It is a multi-center, single-arm, prospective, non-randomized interventional study involving up to 160 subjects across 25 centers in the US. Participants will be followed for 12 months post-procedure to assess outcomes related to the intervention.
Who should consider this trial
Good fit: Ideal candidates include patients with a history of persistent or longstanding persistent atrial fibrillation who require non-emergent open-heart surgery.
Not a fit: Patients with contraindications for anticoagulation therapy or severe heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with persistent atrial fibrillation undergoing cardiac surgery.
How similar studies have performed: Other studies have shown promising results with similar surgical ablation techniques for atrial fibrillation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California and 14 other locations
- Stanford Hospitals and Clinic — Palo Alto, California, United States (Completed)
- Adventist Health St. Helena — St. Helena, California, United States (Withdrawn)
- Hartford Healthcare — Hartford, Connecticut, United States (Completed)
- St Vincent Heart Center of Indiana — Indianapolis, Indiana, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- ProMedica Toledo — Toledo, Ohio, United States (Completed)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Lankenau Medical Center — Wynnewood, Pennsylvania, United States (Completed)
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Completed)
- Virginia Mason Heart Institute — Seattle, Washington, United States (Recruiting)
- Swedish Medical Center — Seattle, Washington, United States (Recruiting)
- St. Joseph Medical Center — Tacoma, Washington, United States (Withdrawn)
Study contacts
- Principal investigator: Ralph J Damiano, MD — Washington University School of Medicine
- Study coordinator: Stephanie Yong
- Email: stephanie.yong@medtronic.com
- Phone: 763-526-2032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.