Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation (AF) increases risks of stroke, heart failure and sudden death. Single catheter ablation only has a low success rate due to inadequate transmurality and continuity of the lesion lines. Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side (Mei Mini Maze procedure, 3M procedure) was applied in our institution in the last 10 years, and gained reasonable results. A more attractive hybrid strategy of epicardial and endocardial ablation was tested to improve the treatment of persistent AF in the investigator's hospital (NCT02968056). Preliminary data from this trial found that insufficient ablation around right upper pulmonary vein area was the key point leading to failure or recurrence. In order to overcome this weakness of the current Mei Mini Maze procedure, concomitant focal epicardial cryoablation performed during the operation may reinforce the lesion lines. The hypothesis of the present study is that additional epicardial cryoablation will improve the success rate compared to Mei Mini Maze procedure alone in the treatment of AF. This study is a prospective randomized controlled trial within a single institution. Lone AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 150 patients in total. The patients will be randomized allocated into Mei Mini Maze procedure group (3M group) and Concomitant epicardial cryoablation group (3M + Cryoablation group). The 3M group patients only have surgical ablation surgery from left thoracoscope as previously reported, while the 3M + Cryoablation group patients will have additional focal epicardial cryoablation around right upper pulmonary vein area after the Mei Mini Maze procedure is done. The ratio of 3M to 3M + cryoablation group is 1:1, so that each group contains 75 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the maintenance of sinus rhythm at 6 months post operation. The secondary outcomes include off antiarrhythmic drug rate, perioperative complications, major cardiovascular events, stroke, left ventricular systolic function, medical expense, serum brain natriuretic peptide level and quality of life. The aim of this study is to evaluate the efficacy and safety of this novel combined procedure of epicardial radiofrequency and cryoablation.

Official Title
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Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation: A Randomized Controlled Trial

Conditions
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Lone Atrial Fibrillation

Intervention / Treatment
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* Procedure: Epicardial focal cryoablation
* Procedure: Mei Mini Maze procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated atrial fibrillation, without structural heart disease. Failed medical treatment Patient admitted with intent to be treated by surgical ablation Exclusion Criteria: Previous surgical ablation of atrial fibrillation Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc. With other forms of severe arrhythmia Ejection fraction of left ventricle less than 30% Anteroposterior diameter of left atrial over 60mm Tumor, active infection, pregnancy. Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc. Hyperthyroidism Thrombosis within left atrial appendage General conditions too weak to tolerate the surgeries Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 6 months follow-up Other conditions not appropriate for this study based on the investigators' judgments

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mei Mini Maze<br>Mei Mini Maze procedure (Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side) | Procedure: Mei Mini Maze procedure<br>* Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side<br>|
| Experimental: Mei Mini Maze plus epicardial cryoablation<br>Epicardial focal cryoablation during Mei Mini Maze procedure | Procedure: Epicardial focal cryoablation<br>* Epicardial focal cryoablation on the left atrium around right upper pulmonary vein area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus rhythm maintenance rate | Based on ECG and Holter results after the surgery, any non-sinus rhythm lasting >30 seconds captured on ECG at any time will be considered failure to maintain sinus rhythm | At 6 months post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off any antiarrhythmic drug rate | Off any antiarrhythmic drug rate | At 6 months post operation | 
| Perioperative complications | Emergent thoracotomy or exploration for bleeding, renal dysfunction requiring new dialysis treatment, respiratory dysfunction requiring prolonged mechanical ventilation with tracheotomy, new pacemaker implantation, and perioperative death | Within 1 month after the surgery | 
| Major cardiovascular events | Death, Nonfatal myocardial infarction, re-admission because of heart disease | Within 6 months post operation | 
| Rate of new onset stroke | New onset of stroke after the surgery, identified by CT or MRI. | Within 6 months post operation | 
| Left ventricular systolic function | Evaluated by ejection fraction from echocardiogram | At 6 months post operation | 
| Costs of treatment | There are 3 parts. 1. Cost during the first hospitalization; 2. Cost of all the health care from first discharge to 6 months after the surgery, including seeing clinics, medication, re-hospitalization related to atrial fibrillation/surgical complications/new onset of stroke/other atrial fibrillation related complications. 3. Total cost: the combination of the abovementioned two parts. | From surgery to 6 months after the surgery | 
| Serum NT-proBNP level | The level of serum NT-proBNP | At 6 months post operation | 
| Quality of life evaluated by short form 36 questionnaire |  | At 6 months post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epicardial cryoablation, epicardial radiofrequency ablation