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Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hybrid procedure
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Ablation, Hybrid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Thoracoscopic ablation group

Hybrid procedure

Arm Description

Patients who will undergo thoracoscopic ablation only

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

Outcomes

Primary Outcome Measures

Cardiac related death
medical records review

Secondary Outcome Measures

Stroke
medical records review at 3, 6 and 12 months follow up
Bleeding
medical records review at 3, 6 and 12 months follow up
Embolism
medical records review at 3, 6 and 12 months follow up
Recurred atrial arrhythmia
medical records review at 3, 6 and 12 months follow up

Full Information

First Posted
November 10, 2014
Last Updated
February 2, 2017
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02392338
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Ablation, Hybrid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracoscopic ablation group
Arm Type
No Intervention
Arm Description
Patients who will undergo thoracoscopic ablation only
Arm Title
Hybrid procedure
Arm Type
Active Comparator
Arm Description
Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)
Intervention Type
Procedure
Intervention Name(s)
Hybrid procedure
Other Intervention Name(s)
Postprocedural electrophysiological study
Intervention Description
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
Primary Outcome Measure Information:
Title
Cardiac related death
Description
medical records review
Time Frame
one year
Secondary Outcome Measure Information:
Title
Stroke
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year
Title
Bleeding
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year
Title
Embolism
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year
Title
Recurred atrial arrhythmia
Description
medical records review at 3, 6 and 12 months follow up
Time Frame
postoperative one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Long-lasting persistent atrial fibrillation Persistent atrial fibrillation refractory to antiarrhythmic drug therapy over 18 years Exclusion Criteria: Valvular heart disease of more than moderate degree Unresponsive ischemic cardiomyopathy Follow-up of over 1 year was not possible Warfarin was unable to be used Refusal of informed consent Left atrial thrombus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Keun On, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22742400
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.
Results Reference
result
PubMed Identifier
31948665
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.
Results Reference
derived

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Hybrid Procedure in Patients With Persistent Atrial Fibrillation

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