Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
Overview
- Phase
- Not Applicable
- Intervention
- Surgical Ablation
- Conditions
- Persistent Atrial Fibrillation
- Sponsor
- Medtronic Cardiac Surgery
- Enrollment
- 160
- Locations
- 28
- Primary Endpoint
- Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
- Status
- Recruiting
- Last Updated
- last month
Overview
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).
Detailed Description
This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.
Investigators
Eligibility Criteria
Inclusion 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)
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
Arms & Interventions
Primary Cohort
Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
Intervention: Surgical Ablation
Primary Cohort
Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery
Intervention: Cardioblate and Cryoflex hand held devices
Outcomes
Primary Outcomes
Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Time Frame: 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.
Composite acute major adverse event rate
Time Frame: 30-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.
Secondary Outcomes
- Percentage of new permanent pacemaker implantation (Safety)(12-months post-procedure)
- Acute procedural success (Efficacy)(During index procedure)
- Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy)(6-months post-procedure)
- Composite acute major adverse event rate (Safety)(12-months post-procedure)
- Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy)(6-months post-procedure)
- Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy)(12-months post-procedure)
- Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Quality of Life Score over time (Efficacy)(12-months post-procedure)
- SF-12 Health Survey (SF-12) Quality of Life Score over time (Efficacy)(12-months post-procedure)
- Composite acute major adverse event rate (Safety)(6-months post-procedure)