NCT03127423

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

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

December 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

December 3, 2016

Last Update Submit

April 25, 2023

Conditions

Persistent Atrial Fibrillation

Keywords

Hybrid ablationThoracoscope

Outcome Measures

Primary Outcomes (1)

  • Survival rate without any recurrence of AF

    Without detections of AF (episodes longer than 30 seconds)

    At 12-month after intervention

Secondary Outcomes (6)

  • Burden of AF

    At 12-month after intervention

  • Quality of life score

    preoperative and 12-month after intervention

  • Adverse events

    12 months follow up

  • Left atrial function

    preoperative and postoperative

  • postoperative complications

    30 days after operation

  • +1 more secondary outcomes

Study Arms (2)

Hybrid ablation group

EXPERIMENTAL

Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation.

Procedure: Hybrid ablation

Thoracoscopic surgical ablation group

ACTIVE COMPARATOR

Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set.

Procedure: Thoracoscopic surgical ablation

Interventions

Hybrid ablationPROCEDURE

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

Hybrid ablation group
Thoracoscopic surgical ablationPROCEDURE

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

Thoracoscopic surgical ablation group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhe Zheng, MD,PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2016

First Posted

April 25, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)