Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392338
• Other study ID #: 2012-10-090
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: February 2, 2017
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Hybrid procedure
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac related death	medical records review	one year
Secondary	Stroke	medical records review at 3, 6 and 12 months follow up	postoperative one year
Secondary	Bleeding	medical records review at 3, 6 and 12 months follow up	postoperative one year
Secondary	Embolism	medical records review at 3, 6 and 12 months follow up	postoperative one year
Secondary	Recurred atrial arrhythmia	medical records review at 3, 6 and 12 months follow up	postoperative one year