Clinical trial NCT02392338: Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Official title: Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Ablation
Hybrid
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac related death
timeFrame: one year
Secondary outcomes:
measure: Stroke
timeFrame: postoperative one year
measure: Bleeding
timeFrame: postoperative one year
measure: Embolism
timeFrame: postoperative one year
measure: Recurred atrial arrhythmia
timeFrame: postoperative one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Keun On, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Choi MS, On YK, Jeong DS, Park KM, Park SJ, Kim JS, Carriere KC. Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation. Am J Cardiol. 2020 Apr 1;125(7):1054-1062. doi: 10.1016/j.amjcard.2019.12.046. Epub 2020 Jan 8.