Actively Recruiting
Medtronic Terminate AF Study
Led by Medtronic Cardiac Surgery · Updated on 2026-05-14
160
Participants Needed
15
Research Sites
419 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
Medtronic Terminate AF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of non-paroxysmal atrial fibrillation (persistent or longstanding persistent)
- Scheduled for non-emergent open-heart surgery such as coronary artery bypass grafting or valve repair/replacement
- Able to take anticoagulant medications like warfarin or novel oral anticoagulants
You will not qualify if you...
- Wolff-Parkinson-White syndrome
- New York Heart Association (NYHA) Class IV heart failure
- Left ventricular ejection fraction 30% or less
- Need for emergency cardiac surgery or repeat open-heart surgery
- Previous atrial fibrillation ablation, AV-nodal ablation, or surgical Maze procedure
- Contraindication to anticoagulation therapy
- Left atrial diameter greater than 6.0 cm
- Preoperative need for intra-aortic balloon pump or intravenous inotropes
- Renal failure requiring dialysis or hepatic failure
- Life expectancy less than 1 year
- Predicted operative mortality risk over 10% by STS Risk Calculator
- Pregnancy or desire to become pregnant within 12 months of treatment
- Active systemic infection or active endocarditis
- Heart attack within 30 days before enrollment
- Current or planned participation in other investigational drug or device trials for atrial arrhythmias
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Stanford Hospitals and Clinic
Palo Alto, California, United States, 94304
Completed
2
Adventist Health St. Helena
St. Helena, California, United States, 94574
Withdrawn
3
Hartford Healthcare
Hartford, Connecticut, United States, 06102
Completed
4
St Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
ProMedica Toledo
Toledo, Ohio, United States, 43606
Completed
9
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
10
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Completed
11
Intermountain Medical Center
Murray, Utah, United States, 84107
Completed
12
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Completed
13
Virginia Mason Heart Institute
Seattle, Washington, United States, 98101
Actively Recruiting
14
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
15
St. Joseph Medical Center
Tacoma, Washington, United States, 98405
Withdrawn
Research Team
S
Stephanie Yong
CONTACT
J
Jessica Halverson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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