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OpenTrials
Completed

NCT Number: NCT02392338

Hybrid Procedure in Patients With Persistent Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid procedure

Procedure

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

Other names: Postprocedural electrophysiological study

Primary outcomes

  1. Cardiac related death

    Time frame: one year

    medical records review

Secondary outcomes

  1. Stroke

    Time frame: postoperative one year

    medical records review at 3, 6 and 12 months follow up

  2. Bleeding

    Time frame: postoperative one year

    medical records review at 3, 6 and 12 months follow up

  3. Embolism

    Time frame: postoperative one year

    medical records review at 3, 6 and 12 months follow up

  4. Recurred atrial arrhythmia

    Time frame: postoperative one year

    medical records review at 3, 6 and 12 months follow up

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 19, 2015
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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