Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hybrid procedure
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Ablation, Hybrid
Eligibility Criteria
Inclusion Criteria:
- Long-lasting persistent atrial fibrillation
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
- over 18 years
Exclusion Criteria:
- Valvular heart disease of more than moderate degree
- Unresponsive ischemic cardiomyopathy
- Follow-up of over 1 year was not possible
- Warfarin was unable to be used
- Refusal of informed consent
- Left atrial thrombus
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Thoracoscopic ablation group
Hybrid procedure
Arm Description
Patients who will undergo thoracoscopic ablation only
Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)
Outcomes
Primary Outcome Measures
Cardiac related death
medical records review
Secondary Outcome Measures
Stroke
medical records review at 3, 6 and 12 months follow up
Bleeding
medical records review at 3, 6 and 12 months follow up
Embolism
medical records review at 3, 6 and 12 months follow up
Recurred atrial arrhythmia
medical records review at 3, 6 and 12 months follow up
Full Information
NCT ID
NCT02392338
First Posted
November 10, 2014
Last Updated
February 2, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02392338
Brief Title
Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Official Title
Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.
Detailed Description
Atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. In Korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years.
Totally thoracoscopic ablation has been adopted and performed successfully on February 2012 at Samsung Medical Center for the first time in Korea. More than 120 operations have been performed up to date.
In Korea, treatment for atrial fibrillation is still dependent on percutaneous RFCA, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. The investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. Also, thoracoscopic ablation and RFCA are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported.
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour Holter monitoring of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Ablation, Hybrid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thoracoscopic ablation group
Arm Type
No Intervention
Arm Description
Patients who will undergo thoracoscopic ablation only
Arm Title
Hybrid procedure
Arm Type
Active Comparator
Arm Description
Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)
Intervention Type
Procedure
Intervention Name(s)
Hybrid procedure
Other Intervention Name(s)
Postprocedural electrophysiological study
Intervention Description
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
Primary Outcome Measure Information:
Title
Cardiac related death
Description
medical records review
Time Frame
one year
Secondary Outcome Measure Information:
Title
Stroke
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year
Title
Bleeding
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year
Title
Embolism
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year
Title
Recurred atrial arrhythmia
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Long-lasting persistent atrial fibrillation
Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
over 18 years
Exclusion Criteria:
Valvular heart disease of more than moderate degree
Unresponsive ischemic cardiomyopathy
Follow-up of over 1 year was not possible
Warfarin was unable to be used
Refusal of informed consent
Left atrial thrombus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Keun On, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22742400
Citation
Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
Results Reference
result
PubMed Identifier
31948665
Citation
Choi MS, On YK, Jeong DS, Park KM, Park SJ, Kim JS, Carriere KC. Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation. Am J Cardiol. 2020 Apr 1;125(7):1054-1062. doi: 10.1016/j.amjcard.2019.12.046. Epub 2020 Jan 8.
Results Reference
derived
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Hybrid Procedure in Patients With Persistent Atrial Fibrillation
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