Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Samsung Medical Center

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Hybrid procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02392338

2012-10-090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Thoracoscopic ablation group

No Intervention group

Description:

Patients who will undergo thoracoscopic ablation only

Hybrid procedure

Active Comparator group

Description:

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

Treatment:

Procedure: Hybrid procedure