One Staged Hybrid Approach of Surgical/Catheter Ablation for Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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There are 10 million atrial fibrillation (AF) patients in China, and the patients are risk of stroke, heart failure and sudden death. Persistent AF is still a refractory disease, and single catheter ablation only has a success rate around 30-50%. Hybrid strategy consisting of thoracoscopic epicardial ablation and transvenous endocardial ablation seems to be an attractive procedure to improve the treatment of persistent AF. However, only a few centers reported their preliminary results, and the conclusions are controversial. The investigator previously reported a minimally invasive surgical ablation from left thoracoscope only and achieved good results. Recently, the investigator successfully explored a hybrid procedure combing this unique surgical technique and transvenous catheter ablation. Here, the investigator present a study to evaluate the efficacy and safety of this novel hybrid procedure. The hypothesis is that a hybrid approach is more efficient than surgical ablation alone in the treatment of persistent AF. This study is a non-randomized controlled study within a single institution. Isolated persistent AF patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will be screened for enrollment of this study. The study will recruit 180 patients in total. Based on their own willingness, the patients will be divided into hybrid group and minimally invasive (MIS) group. The MIS group patients only have surgical ablation surgery from left thoracoscope as the investigator reported before, while the hybrid group patients will have additional transvenous catheter ablation after the surgical ablation is done during the same operation. The ratio of hybrid to MIS group is expected to be 1:1, so that each group contains 90 patients. The perioperative data is collected, and the patients will be followed for 6 months. The primary outcome is the rate 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 is to evaluate the efficacy and safety of this novel hybrid procedure, therefore to provide more evidence of the hybrid strategy in the treatment of persistent AF.

Official Title
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One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Isolated atrial fibrillation, without structural heart disease. Persistent atrial fibrillation (Af last time > 7 days, including persistent long standing atrial fibrillation) Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication; symptomatic patients are those who have been aware of their AF at any time within the last 5 years before enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of these. Patient admitted with intent to treat by either hybrid or surgical ablation Consent 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 1-year 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

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid group<br>Minimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure | Procedure: Radiofrequency ablation<br>* Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)<br>|
| Active Comparator: MIS group<br>Minimally invasive surgical radiofrequency ablation of atrial fibrillation only | Procedure: Radiofrequency ablation<br>* Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)<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 results from 3 months and 6 months 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 after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off any antiarrhythmic drug rate | The rate is counted at 6 months | 6 months after the surgery | 
| 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 after discharge | 
| Stroke | New onset of stroke after the surgery | Within 6 months after the surgery | 
| Left ventricular systolic function | Evaluated by ejection fraction from echocardiogram | At 6 months after the surgery | 
| Costs of treatment in Chinese Yuan | 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 brain natriuretic peptide level |  | 6 months after the surgery | 
| Quality of life | Evaluated by short form 36 questionnaire | 6 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, radiofrequency ablation