Medtronic Terminate AF Study for Atrial Fibrillation
This study is testing the safety and effectiveness of two medical devices, the Cardioblate iRF and CryoFlex, for treating persistent or longstanding persistent atrial fibrillation (AF). AF is an irregular and often rapid heart rate that can cause symptoms like palpitations, fatigue, and shortness of breath. You may be able to join if you have non-paroxysmal AF and are already scheduled for open-heart surgery, such as bypass surgery or valve repair. The study will look at how many serious problems happen within 30 days of the procedure and if your AF is gone between 6 and 12 months after the procedure. This study is currently unclear on its recruitment status and plans to enroll up to 160 participants.
- Study design
- This is a single-arm study, meaning all participants will receive the treatment being tested. Up to 160 people will take part in this study across various centers in the United States.
- What's involved
- Participants will undergo a surgical ablation procedure using the Cardioblate iRF and CryoFlex devices during their planned open-heart surgery. You will be followed and assessed for 12 months after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed and assessed for 12 months after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Medtronic Terminate AF Study
At a glance
Conditions
NCT03546374
Where you'd take part
This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Allegheny General Hospital
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Corewell Health
Grand Rapids, Michiganstudy coordinator listed
Recruiting
Massachusetts General Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
St Vincent Heart Center of Indiana
Indianapolis, Indianastudy coordinator listed
Recruiting
Swedish Medical Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Virginia Mason Heart Institute
Seattle, Washingtonstudy coordinator listed
Recruiting
Washington University School of Medicine
St Louis, Missouristudy coordinator listed
Recruiting
Adventist Health St. Helena
St. Helena, Californiano site contact published
Withdrawn
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ralph J Damiano, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Composite acute major adverse event rate30-days post-procedure or hospital discharge (whichever is longer)
Composite acute major adverse event rate including: Atrial tears, Esophageal injury, Excessive bleeding, Mediastinitis, Myocardial infarction (MI), Pulmonary embolism, Peripheral arterial embolism, Stroke, Transient ischemic attacks (TIA), Death.
- Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)6-months post-procedure to 12-months post-procedure
Freedom from AF/AFL/AT of 30 seconds or greater duration on Holter, and 10 seconds on 12-lead ECG after removal from antiarrhythmic drug (AAD) therapy.