Clinical trial NCT03708471: Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation
Official title: Efficacy of Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Hybrid ablation
Surgical ablation
Lead sponsor: Guangdong Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Atrial tachyarrhythmia recurrence
timeFrame: 24 months after blanking-period.
Secondary outcomes:
measure: Systemic atrial embolism
timeFrame: 24 months after blanking-period.
measure: Left atrial thrombus
timeFrame: At 3months, 6months, 12months, 18months, 24months after intervention.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
References: