An interventional study of Hybrid procedure in Atrial Fibrillation, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-03.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 60 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who will undergo thoracoscopic ablation only
Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)
Procedure: Hybrid procedure
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
Also known as: Postprocedural electrophysiological study
Cardiac related death
medical records review
Time frame: one year
Stroke
medical records review at 3, 6 and 12 months follow up
Time frame: postoperative one year
Bleeding
medical records review at 3, 6 and 12 months follow up
Time frame: postoperative one year
Embolism
medical records review at 3, 6 and 12 months follow up
Time frame: postoperative one year
Recurred atrial arrhythmia
medical records review at 3, 6 and 12 months follow up
Time frame: postoperative one year
Plan to share: No
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center