Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Hybrid ablation, Surgical ablation
Brief summary
Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it. This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.
Detailed description
In this study, all selected LSPAF patients will receive thoracoscopic surgical ablation. After 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into Hybrid group and Surgical group randomly and equally. Patients of Hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. In followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients. During the 2-year follow-up, 7d-Holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (TTE). Physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.
Interventions
PROCEDUREHybrid ablation
This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
PROCEDUREThoracoscopic surgical ablation
This intervention including thoracoscopic surgical ablation and cardiovascular risk control.
Sponsors
Guangdong Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Older than 18 years old. * Nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively. * Written informed consent
Exclusion criteria
* Secondary atrial fibrillation caused by other reversible diseases. * Left atrial diameter \>55mm confrimed by Transthoracic echocardiography. * Intracardial mass or thrombus. * Previous cardiac surgery. * Uncontrolled heart failure or LVEF less than 30%. * Severe chest wall deformity. * Possibly pleural adhesion or pericardial adhesion caused by previous thoracic surgery, tuberculosis or constrictive pericarditis. * Severe comorbidities (e.g. severe CAD, severe renal failure, severe liver failure). * Life expectancy less than 2 years (e.g. patients with MODS or cancer) * Unsuitable for radiation exposure (e.g. pregnancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial tachyarrhythmia recurrence | 24 months after blanking-period. | Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic atrial embolism | 24 months after blanking-period. | Including cerebral infarction and other peripheral atrial embolism |
| Left atrial thrombus | At 3months, 6months, 12months, 18months, 24months after intervention. | New-onset left atrial thrombus confirmed by TEE or TTE |
Countries
China
Contacts
Primary ContactHuiming Guo, MD, PhD
Outcome results
None listed