Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Persistent Atrial Fibrillation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03127423

2016-828

Details and patient eligibility

About

Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Full description

This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with at least one anti-arrhythmic drugs
• Persistent AF lasting more than 1 year or with a left atrial diameter>50mm

Exclusion criteria

• Previous percutaneous catheter ablation or surgical ablation
• Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
• Left atrial diameter>60mm
• Previous thoracic or lung operation
• Left atrial thrombosis or left atrial appendage thrombosis
• Chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC)<70%、FEV1<50% anticipated value)
• Bilateral carotid artery stenosis>80%
• Refuse to participate in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Hybrid ablation group

Experimental group

Description:

Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation.

Treatment:

Procedure: Hybrid ablation

Thoracoscopic surgical ablation group

Active Comparator group

Description:

Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set.

Treatment:

Procedure: Thoracoscopic surgical ablation