Medtronic Terminate AF Study

Launched by MEDTRONIC CARDIAC SURGERY · Jun 1, 2018

Keywords

ClinConnect Summary

The Medtronic Terminate AF Study is looking to find out how safe and effective two specific devices, called Cardioblate iRF and CryoFlex, are for treating a type of irregular heartbeat known as non-paroxysmal atrial fibrillation (AF). This includes patients who have been living with persistent or longstanding AF. The study is currently recruiting participants aged 65 to 74, and anyone can join regardless of gender, as long as they meet certain health criteria.

To be eligible, participants should have a history of non-paroxysmal AF and need to undergo non-emergency heart surgery, such as heart bypass or valve replacement. They also need to be able to take blood-thinning medications. However, some people may not qualify, such as those with severe heart conditions or certain medical issues that could complicate surgery. If you decide to participate, you can expect to be closely monitored during the study, and your involvement could help improve treatments for atrial fibrillation in the future.

Gender

ALL

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
• • NYHA Class = IV
• • Left Ventricular Ejection Fraction ≤ 30%
• • Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
• • Previous AF ablation, 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