Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation (THAT-LSPAF)

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

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.

Study Overview

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

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong General Hospital
      • Contact: Huiming Guo, MD., PhD.; Phone Number: +86 13609089789; Email: guohuiming@163.net
      • Sub-Investigator: Yuyuan Zhang, Jr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

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: Two-stage hybrid abltaion; After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control.	Procedure: Hybrid ablation; This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
Active Comparator: Thoracosopic surgical ablation; After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control.	Procedure: Thoracoscopic surgical ablation; This intervention including thoracoscopic surgical ablation and cardiovascular risk control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic atrial embolism	Including cerebral infarction and other peripheral atrial embolism	24 months after blanking-period.
Left atrial thrombus	New-onset left atrial thrombus confirmed by TEE or TTE	At 3months, 6months, 12months, 18months, 24months after intervention.

Collaborators and Investigators

• Sponsor: Guangdong Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2018
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Hybrid ablation; Surgical ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: THAT-LSPAF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No