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

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.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Hybrid ablation; Procedure: Thoracoscopic surgical ablation

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Zheng, MD,PhD; Phone Number: 86-10-88396051; Email: zhengzhe@fuwai.com
• Study Contact Backup: Name: Haojie Li, MD; Phone Number: 86-10-88322317; Email: lihaojiefuwai@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • China National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid ablation group; Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation.	Procedure: Hybrid ablation; This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.
Active Comparator: Thoracoscopic surgical ablation group; Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set.	Procedure: Thoracoscopic surgical ablation; This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate without any recurrence of AF	Without detections of AF (episodes longer than 30 seconds)	At 12-month after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 3, 2016
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hybrid ablation; Thoracoscope
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2016-828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO