NCT03546374Recruiting
Medtronic Terminate AF Study
Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 9 May 2018
- Start date
- 15 Nov 2018
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Medtronic Cardiac Surgery
- Diseases
- Atrial fibrillation
- NCT number
- NCT03546374
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 15 Nov 2018 to the primary completion date, 1 Oct 2024
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Maze procedure
- Contraindication for anticoagulation therapy
- Documented MI 30 days prior to study enrollment
Other illness
- Wolff-Parkinson-White syndrome
- New York Heart Association (NYHA) Class = IV
- Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
- Renal failure requiring dialysis or hepatic failure
- Current diagnosis of active systemic infection
- Current or planned participation in an investigational or observational drug or device trial related to the treatment of atrial arrhythmias
Lab values
- Left Ventricular Ejection Fraction ≤ 30%
Other
- Left atrial diameter \> 6.0 cm
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- 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
- Active endocarditis
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Corewell Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Hartford Healthcare Coordinator of this site? Confirm its status | Hartford | United States | Completed |
| St. Vincent Heart Center of Indiana Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Completed |
| Sentara Norfolk General Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Completed |
| Stanford Hospitals and Clinic Coordinator of this site? Confirm its status | Palo Alto | United States | Completed |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Virginia Mason Heart Institute Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Swedish Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Adventist Health St. Helena Coordinator of this site? Confirm its status | St. Helena | United States | Withdrawn |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| St. Joseph Medical Center Coordinator of this site? Confirm its status | Tacoma | United States | Withdrawn |
| ProMedica Toledo Coordinator of this site? Confirm its status | Toledo | United States | Completed |
| Lankenau Medical Center Coordinator of this site? Confirm its status | Wynnewood | United States | Completed |
Related publications
- A prospective, multicenter trial of irrigated radiofrequency ablation and cryoablation to treat nonparoxysmal atrial fibrillation.J Thorac Cardiovasc Surg · 2026 · PMID 42092502
This page is information, not medical advice. Discuss any trial with your doctor.