Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Hybrid procedure

• Registration Number: NCT02392338
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hybrid procedure	Hybrid procedure	Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)

Primary Outcome Measures

Name	Time	Method
Cardiac related death	one year	medical records review

Secondary Outcome Measures

Name	Time	Method
Bleeding	postoperative one year	medical records review at 3, 6 and 12 months follow up
Embolism	postoperative one year	medical records review at 3, 6 and 12 months follow up
Stroke	postoperative one year	medical records review at 3, 6 and 12 months follow up
Recurred atrial arrhythmia	postoperative one year	medical records review at 3, 6 and 12 months follow up

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of