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

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Hybrid ablation; Procedure: Thoracoscopic surgical ablation

• Registration Number: NCT03127423
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-03
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid ablation group	Hybrid ablation	Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation.
Thoracoscopic surgical ablation group	Thoracoscopic surgical ablation	Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set.

Primary Outcome Measures

Name	Time	Method
Survival rate without any recurrence of AF	At 12-month after intervention	Without detections of AF (episodes longer than 30 seconds)

Secondary Outcome Measures

Name	Time	Method
Burden of AF	At 12-month after intervention	Burden of AF according to Tele-ECG-Card lasting for one week
Quality of life score	preoperative and 12-month after intervention	Measured with questionnaire of AF effect on Quality of Life
Adverse events	12 months follow up	Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events.
Left atrial function	preoperative and postoperative	left atrial ejection fraction and left atrial expansion index
Survival rate without any recurrence of atrial tachyarrhythmia	At 12-month after intervention	Survival rate without AF, atrial flutter or atrial tachycardia will be defined by absence of any of these electrocardiographically documented events lasting \> 30 seconds.
postoperative complications	30 days after operation	perioperative complication of catheter ablation and thoracoscopic surgical abaltion

Trial Locations

Locations (1)

China National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China