Medtronic Terminate AF Study

Study Overview
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Brief Summary
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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 AF.

Detailed Description
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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 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.

Official Title
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Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)

Conditions
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Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Surgical Ablation
* Device: Cardioblate and Cryoflex hand held devices


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Cohort<br>Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery | Procedure: Surgical Ablation<br>* In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.<br>Device: Cardioblate and Cryoflex hand held devices<br>* The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite acute major adverse event rate | 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. | 30-days post-procedure or hospital discharge (whichever is longer) | 
| Freedom from Atrial Fibrillation (AF)/Atrial Flutter (AFL)/Atrial Tachycardia (AT) | 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. | 6-months post-procedure to 12-months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite acute major adverse event rate (Safety) | Composite acute major adverse event rate at 6 months post-procedure (as defined above) | 6-months post-procedure | 
| Composite acute major adverse event rate (Safety) | Composite acute major adverse event rate at 12 months post-procedure (as defined above) | 12-months post-procedure | 
| Percentage of new permanent pacemaker implantation (Safety) | Percentage of new permanent pacemaker implantation presented by indication | 12-months post-procedure | 
| Acute procedural success (Efficacy) | Acute procedural success (pulmonary vein isolation) | During index procedure | 
| Freedom from AF/AFL/AT after removal of AAD therapy through 6-months post-procedure (Efficacy) | Freedom from AF/AFL/AT of 30 seconds or greater duration after removal from AAD therapy as assessed from the end of the 3-month blanking period through 6 months post-procedure | 6-months post-procedure | 
| Freedom from AF/AFL/AT through 6-months post-procedure (Efficacy) | Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 6 months post-procedure | 6-months post-procedure | 
| Freedom from AF/AFL/AT through 12-months post-procedure (Efficacy) | Freedom from AF/AFL/AT of 30 seconds or greater duration regardless of AAD status through 12 months post-procedure | 12-months post-procedure | 
| AFEQT Quality of Life Score over time (Efficacy) | Characterization of quality of life scores over time as assessed by AFEQT questionnaire. AFEQT overall score ranges from 0-100. Zero corresponds to complete disability and 100 corresponds to no disability. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval. | 12-months post-procedure | 
| SF-12 Quality of Life Score over time (Efficacy) | Characterization of quality of life scores over time as assessed by SF-12 questionnaire. SF-12 overall score ranges from 0-100. Zero indicates the lowest level of health measured by the scale and 100 indicates the highest level of health. The means, medians, standard deviations, interquartile ranges, minima, and maxima will be provided for the quality of life scores by visit interval. | 12-months post-procedure |