Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation (THAT-LSPAF)

Guangdong Academy of Medical Sciences

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: Hybrid ablation; Procedure: Thoracoscopic surgical ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03708471

THAT-LSPAF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Two-stage hybrid abltaion

Experimental group

Description:

After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control.

Treatment:

Procedure: Hybrid ablation

Thoracosopic surgical ablation

Active Comparator group

Description:

After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control.

Treatment:

Procedure: Thoracoscopic surgical ablation