Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— THAT-LSPAF  

Official title:

Efficacy of Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation: A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03708471
• Other study ID #: THAT-LSPAF
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2018
• Est. completion date: December 2022

Study information

• Verified date: February 2020
• Source: Guangdong Academy of Medical Sciences
• Contact: Huiming Guo, MD, PhD
• Phone: +86 13609089789
• Email: guohuiming[@]163.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Hybrid ablation
This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
• Thoracoscopic surgical ablation
This intervention including thoracoscopic surgical ablation and cardiovascular risk control.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial tachyarrhythmia recurrence	Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.	24 months after blanking-period.
Secondary	Systemic atrial embolism	Including cerebral infarction and other peripheral atrial embolism	24 months after blanking-period.
Secondary	Left atrial thrombus	New-onset left atrial thrombus confirmed by TEE or TTE	At 3months, 6months, 12months, 18months, 24months after intervention.