- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708471
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
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huiming Guo, MD, PhD
- Phone Number: +86 13609089789
- Email: guohuiming@163.net
Study Locations
-
-
Guangdong
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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
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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
Time Frame: 24 months after blanking-period.
|
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
Time Frame: 24 months after blanking-period.
|
Including cerebral infarction and other peripheral atrial embolism
|
24 months after blanking-period.
|
Left atrial thrombus
Time Frame: At 3months, 6months, 12months, 18months, 24months after intervention.
|
New-onset left atrial thrombus confirmed by TEE or TTE
|
At 3months, 6months, 12months, 18months, 24months after intervention.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THAT-LSPAF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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