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Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02392338
Enrollment
60
Registered
2015-03-19
Start date
2014-11-30
Completion date
2016-12-31
Last updated
2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Ablation, Hybrid

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.

Interventions

Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Long-lasting persistent atrial fibrillation 2. Persistent atrial fibrillation refractory to antiarrhythmic drug therapy 3. over 18 years

Exclusion criteria

1. Valvular heart disease of more than moderate degree 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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac related deathone yearmedical records review

Secondary

MeasureTime frameDescription
Strokepostoperative one yearmedical records review at 3, 6 and 12 months follow up
Bleedingpostoperative one yearmedical records review at 3, 6 and 12 months follow up
Embolismpostoperative one yearmedical records review at 3, 6 and 12 months follow up
Recurred atrial arrhythmiapostoperative one yearmedical records review at 3, 6 and 12 months follow up

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026