Back to resultsComparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
Primary Purpose
Persistent Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hybrid ablation
Thoracoscopic surgical ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Hybrid ablation, Thoracoscope
Eligibility Criteria
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
Sites / Locations
- China National Center for Cardiovascular Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hybrid ablation group
Thoracoscopic surgical ablation group
Arm Description
Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation.
Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set.
Outcomes
Primary Outcome Measures
Survival rate without any recurrence of AF
Without detections of AF (episodes longer than 30 seconds)
Secondary Outcome Measures
Burden of AF
Burden of AF according to Tele-ECG-Card lasting for one week
Quality of life score
Measured with questionnaire of AF effect on Quality of Life
Adverse events
Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events.
Left atrial function
left atrial ejection fraction and left atrial expansion index
postoperative complications
perioperative complication of catheter ablation and thoracoscopic surgical abaltion
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.
Full Information
NCT ID
NCT03127423
First Posted
December 3, 2016
Last Updated
April 25, 2023
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT03127423
Brief Title
Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
Official Title
Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Hybrid ablation, Thoracoscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hybrid ablation group
Arm Type
Experimental
Arm Description
Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation.
Arm Title
Thoracoscopic surgical ablation group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set.
Intervention Type
Procedure
Intervention Name(s)
Hybrid ablation
Intervention Description
This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.
Intervention Type
Procedure
Intervention Name(s)
Thoracoscopic surgical ablation
Intervention Description
This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.
Primary Outcome Measure Information:
Title
Survival rate without any recurrence of AF
Description
Without detections of AF (episodes longer than 30 seconds)
Time Frame
At 12-month after intervention
Secondary Outcome Measure Information:
Title
Burden of AF
Description
Burden of AF according to Tele-ECG-Card lasting for one week
Time Frame
At 12-month after intervention
Title
Quality of life score
Description
Measured with questionnaire of AF effect on Quality of Life
Time Frame
preoperative and 12-month after intervention
Title
Adverse events
Description
Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events.
Time Frame
12 months follow up
Title
Left atrial function
Description
left atrial ejection fraction and left atrial expansion index
Time Frame
preoperative and postoperative
Title
postoperative complications
Description
perioperative complication of catheter ablation and thoracoscopic surgical abaltion
Time Frame
30 days after operation
Title
Survival rate without any recurrence of atrial tachyarrhythmia
Description
Survival rate without AF, atrial flutter or atrial tachycardia will be defined by absence of any of these electrocardiographically documented events lasting > 30 seconds.
Time Frame
At 12-month after intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD,PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
China National Center for Cardiovascular Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
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