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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hybrid ablation
Thoracoscopic surgical ablation
Sponsored by
Guangdong Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Hybrid ablation, Surgical ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Two-stage hybrid abltaion

Thoracosopic surgical ablation

Arm Description

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.

After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control.

Outcomes

Primary Outcome Measures

Atrial tachyarrhythmia recurrence
Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.

Secondary Outcome Measures

Systemic atrial embolism
Including cerebral infarction and other peripheral atrial embolism
Left atrial thrombus
New-onset left atrial thrombus confirmed by TEE or TTE

Full Information

First Posted
October 14, 2018
Last Updated
February 10, 2020
Sponsor
Guangdong Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03708471
Brief Title
Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 4, 2018 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Hybrid ablation, Surgical ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two-stage hybrid abltaion
Arm Type
Experimental
Arm Description
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.
Arm Title
Thoracosopic surgical ablation
Arm Type
Active Comparator
Arm Description
After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control.
Intervention Type
Procedure
Intervention Name(s)
Hybrid ablation
Intervention Description
This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
Intervention Type
Procedure
Intervention Name(s)
Thoracoscopic surgical ablation
Intervention Description
This intervention including thoracoscopic surgical ablation and cardiovascular risk control.
Primary Outcome Measure Information:
Title
Atrial tachyarrhythmia recurrence
Description
Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.
Time Frame
24 months after blanking-period.
Secondary Outcome Measure Information:
Title
Systemic atrial embolism
Description
Including cerebral infarction and other peripheral atrial embolism
Time Frame
24 months after blanking-period.
Title
Left atrial thrombus
Description
New-onset left atrial thrombus confirmed by TEE or TTE
Time Frame
At 3months, 6months, 12months, 18months, 24months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huiming Guo, MD, PhD
Phone
+86 13609089789
Email
guohuiming@163.net
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiming Guo, MD., PhD.
Phone
+86 13609089789
Email
guohuiming@163.net
First Name & Middle Initial & Last Name & Degree
Yuyuan Zhang, Jr.

12. IPD Sharing Statement

Learn more about this trial

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

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