Hybrid Procedure in Patients With Persistent Atrial Fibrillation
NCT ID: NCT02392338
Last Updated: 2017-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-11-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thoracoscopic ablation group
Patients who will undergo thoracoscopic ablation only
No interventions assigned to this group
Hybrid procedure
Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)
Hybrid procedure
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
Interventions
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Hybrid procedure
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
3. over 18 years
Exclusion Criteria
2. Unresponsive ischemic cardiomyopathy
3. Follow-up of over 1 year was not possible
4. Warfarin was unable to be used
5. Refusal of informed consent
6. Left atrial thrombus
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Young Keun On
Professor
Principal Investigators
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Young Keun On, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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References
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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.
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.
Other Identifiers
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2012-10-090
Identifier Type: -
Identifier Source: org_study_id
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