Lone Atrial Fibrillation
Conditions
Keywords
epicardial cryoablation, epicardial radiofrequency ablation
Brief summary
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.
Interventions
PROCEDUREEpicardial focal cryoablation
Epicardial focal cryoablation on the left atrium around right upper pulmonary vein area
PROCEDUREMei Mini Maze procedure
Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Isolated atrial fibrillation, without structural heart disease. 2. Failed medical treatment 3. Patient admitted with intent to be treated by surgical ablation
Exclusion criteria
1. Previous surgical ablation of atrial fibrillation 2. Concomitant other cardiac diseases which require surgery at the same procedure, such as heart valve disease, congenital heart disease, coronary disease, dilated cardiomyopathy etc. 3. With other forms of severe arrhythmia 4. Ejection fraction of left ventricle less than 30% 5. Anteroposterior diameter of left atrial over 60mm 6. Tumor, active infection, pregnancy. 7. Previous surgeries with left thoracotomy, or expected left pleural adhesion, such as history of tuberculosis infection, pleural effusion, pneumothorax etc. 8. Hyperthyroidism 9. Thrombosis within left atrial appendage 10. General conditions too weak to tolerate the surgeries 11. Patient's circumstance that precludes completion of follow-up and/or obtaining information from the 6 months follow-up 12. Other conditions not appropriate for this study based on the investigators' judgments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sinus rhythm maintenance rate | At 6 months post operation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complications | Within 1 month after the surgery | 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 |
| Major cardiovascular events | Within 6 months post operation | Death, Nonfatal myocardial infarction, re-admission because of heart disease |
| Rate of new onset stroke | Within 6 months post operation | New onset of stroke after the surgery, identified by CT or MRI. |
| Off any antiarrhythmic drug rate | At 6 months post operation | Off any antiarrhythmic drug rate |
| Costs of treatment | From surgery to 6 months after the surgery | 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. |
| Serum NT-proBNP level | At 6 months post operation | The level of serum NT-proBNP |
| Quality of life evaluated by short form 36 questionnaire | At 6 months post operation | — |
| Left ventricular systolic function | At 6 months post operation | Evaluated by ejection fraction from echocardiogram |
Contacts
Primary ContactJiaquan Zhu, MD & Ph.D
Outcome results
None listed