One Staged Hybrid Approach of Surgical/Catheter Ablation for Persistent Atrial Fibrillation
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Procedure: Radiofrequency ablation
- Registration Number
- NCT02968056
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MIS group Radiofrequency ablation Minimally invasive surgical radiofrequency ablation of atrial fibrillation only Hybrid group Radiofrequency ablation Minimally invasive surgical radiofrequency ablation of atrial fibrillation followed by catheterized radiofrequency ablation within the same procedure
- Primary Outcome Measures
Name Time Method Sinus rhythm maintenance rate At 6 months after the surgery 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
- Secondary Outcome Measures
Name Time Method Serum brain natriuretic peptide level 6 months after the surgery Off any antiarrhythmic drug rate 6 months after the surgery The rate is counted at 6 months
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 after discharge Death, Nonfatal myocardial infarction, re-admission because of heart disease
Left ventricular systolic function At 6 months after the surgery Evaluated by ejection fraction from echocardiogram
Stroke Within 6 months after the surgery New onset of stroke after the surgery
Costs of treatment in Chinese Yuan 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.
Quality of life 6 months after the surgery Evaluated by short form 36 questionnaire
Trial Locations
- Locations (1)
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China