Persistent Atrial Fibrillation study: Surgical Ablation
Official title Medtronic Terminate AF Study
ClinicalTrials.gov ID: NCT03546374
What this study is testing
- What it's testing
- The study aims to show whether the Cardioblate iRF and CryoFlex devices are safe and work for treating non‑paroxysmal atrial fibrillation.
- Who it's for
- Adults who have persistent or longstanding persistent atrial fibrillation.
- What's involved
- Participants will receive treatment with the handheld iRF or CryoFlex device during a procedure.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Indianapolis, Indiana, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; St Louis, Missouri, United States; Pittsburgh, Pennsylvania, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.