🏛️ Verified NIH Record • Updated 2026-05-07
Medtronic Terminate AF Study (NCT03546374)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Medtronic Cardiac Surgery
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (17 items).
Location: Stanford Hospitals and Clinic — Palo Alto, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Stanford Hospitals and Clinic — Palo Alto, California
- Adventist Health St. Helena — St. Helena, California
- Hartford Healthcare — Hartford, Connecticut
- St Vincent Heart Center of Indiana — Indianapolis, Indiana
- Massachusetts General Hospital — Boston, Massachusetts
- Corewell Health — Grand Rapids, Michigan
- Washington University School of Medicine — St Louis, Missouri
- ProMedica Toledo — Toledo, Ohio
- Allegheny General Hospital — Pittsburgh, Pennsylvania
- Lankenau Medical Center — Wynnewood, Pennsylvania
- Intermountain Medical Center — Murray, Utah
- Sentara Norfolk General Hospital — Norfolk, Virginia
- Virginia Mason Heart Institute — Seattle, Washington
- Swedish Medical Center — Seattle, Washington
- St. Joseph Medical Center — Tacoma, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.