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Completed

NCT Number: NCT03127423

Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation

Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

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Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

About this study

This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with at least one anti-arrhythmic drugs
  • Persistent AF lasting more than 1 year or with a left atrial diameter>50mm

Exclusion criteria

  • Previous percutaneous catheter ablation or surgical ablation
  • Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
  • Left atrial diameter>60mm
  • Previous thoracic or lung operation
  • Left atrial thrombosis or left atrial appendage thrombosis
  • Chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC)<70%、FEV1<50% anticipated value)
  • Bilateral carotid artery stenosis>80%
  • Refuse to participate in this study

Treatment and study plan

Hybrid Ablation

Procedure

This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.

Thoracoscopic surgical ablation

Procedure

This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.

Primary outcomes

  1. Survival rate without any recurrence of AF

    Time frame: At 12-month after intervention

    Without detections of AF (episodes longer than 30 seconds)

Secondary outcomes

  1. Burden of AF

    Time frame: At 12-month after intervention

    Burden of AF according to Tele-ECG-Card lasting for one week

  2. Quality of life score

    Time frame: preoperative and 12-month after intervention

    Measured with questionnaire of AF effect on Quality of Life

  3. Adverse events

    Time frame: 12 months follow up

    Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events.

  4. Left atrial function

    Time frame: preoperative and postoperative

    left atrial ejection fraction and left atrial expansion index

  5. postoperative complications

    Time frame: 30 days after operation

    perioperative complication of catheter ablation and thoracoscopic surgical abaltion

  6. Survival rate without any recurrence of atrial tachyarrhythmia

    Time frame: At 12-month after intervention

    Survival rate without AF, atrial flutter or atrial tachycardia will be defined by absence of any of these electrocardiographically documented events lasting > 30 seconds.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2017
Registry last updated
Apr 27, 2023

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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