NCT02392338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

November 10, 2014

Last Update Submit

February 2, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationAblationHybrid

Outcome Measures

Primary Outcomes (1)

  • Cardiac related death

    medical records review

    one year

Secondary Outcomes (4)

  • Stroke

    postoperative one year

  • Bleeding

    postoperative one year

  • Embolism

    postoperative one year

  • Recurred atrial arrhythmia

    postoperative one year

Study Arms (2)

Thoracoscopic ablation group

NO INTERVENTION

Patients who will undergo thoracoscopic ablation only

Hybrid procedure

ACTIVE COMPARATOR

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

Procedure: Hybrid procedure

Interventions

Hybrid procedurePROCEDURE

Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium

Also known as: Postprocedural electrophysiological study
Hybrid procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Long-lasting persistent atrial fibrillation
  • Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
  • over 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 22742400RESULT

  • 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.

    PMID: 31948665DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Young Keun On, MD,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2014

First Posted

March 19, 2015

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)