| NCT ID | NCT03546374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Cardiac Surgery |
| Condition | Persistent Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2018-11-15 |
| Primary Completion | 2024-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2018-11-15 with a primary completion date of 2024-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * History of non-paroxysmal AF (persistent or longstanding persistent) * Concomitant indication for non-emergent open-heart surgery, eg, 1. Coronary artery bypass grafting 2. Valve repair or replacement * Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC) 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 * 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
Contact & Investigator
Ralph J Damiano, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT03546374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03546374 currently recruiting?
Yes, NCT03546374 is actively recruiting participants. Contact the research team at stephanie.yong@medtronic.com for enrollment information.
Where is the NCT03546374 trial being conducted?
This trial is being conducted at Palo Alto, United States, St. Helena, United States, Hartford, United States, Indianapolis, United States and 11 additional locations.
Who is sponsoring the NCT03546374 clinical trial?
NCT03546374 is sponsored by Medtronic Cardiac Surgery. The principal investigator is Ralph J Damiano, MD at Washington University School of Medicine. The trial plans to enroll 160 participants.
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