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

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127423
• Other study ID #: 2016-828
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2022

Study information

• Verified date: April 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Hybrid ablation
This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.
• Thoracoscopic surgical ablation
This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.

Locations

Country	Name	City	State
China	China National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate without any recurrence of AF	Without detections of AF (episodes longer than 30 seconds)	At 12-month after intervention
Secondary	Burden of AF	Burden of AF according to Tele-ECG-Card lasting for one week	At 12-month after intervention
Secondary	Quality of life score	Measured with questionnaire of AF effect on Quality of Life	preoperative and 12-month after intervention
Secondary	Adverse events	Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events.	12 months follow up
Secondary	Left atrial function	left atrial ejection fraction and left atrial expansion index	preoperative and postoperative
Secondary	postoperative complications	perioperative complication of catheter ablation and thoracoscopic surgical abaltion	30 days after operation
Secondary	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