Clinical trial NCT02968056: One Staged Hybrid Approach of Surgical/Catheter Ablation for Persistent Atrial Fibrillation
Official title: One Staged Hybrid Approach of Minimally Invasively Surgical/Catheter Ablation for Persistent Atrial Fibrillation: A Non-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: atrial fibrillation
radiofrequency ablation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria

1. Isolated atrial fibrillation, without structural heart disease.
2. Persistent atrial fibrillation (Af last time \> 7 days, including persistent long standing atrial fibrillation)
3. 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.
4. Patient admitted with intent to treat by either hybrid or surgical ablation
5. Consent

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 1-year follow-up
12. Other conditions not appropriate for this study based on the investigators' judgments

Primary outcomes:
measure: Sinus rhythm maintenance rate
timeFrame: At 6 months after the surgery
Secondary outcomes:
measure: Off any antiarrhythmic drug rate
timeFrame: 6 months after the surgery
measure: Perioperative complications
timeFrame: Within 1 month after the surgery
measure: Major cardiovascular events
timeFrame: Within 6 months after discharge
measure: Stroke
timeFrame: Within 6 months after the surgery
measure: Left ventricular systolic function
timeFrame: At 6 months after the surgery
measure: Costs of treatment in Chinese Yuan
timeFrame: From surgery to 6 months after the surgery
measure: Serum brain natriuretic peptide level
timeFrame: 6 months after the surgery
measure: Quality of life
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Xin Zhou, MD
role: STUDY_DIRECTOR
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