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

NCT ID: NCT03127423

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hybrid ablation group

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

Group Type EXPERIMENTAL

Hybrid ablation

Intervention Type PROCEDURE

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

Thoracoscopic surgical ablation group

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

Group Type ACTIVE_COMPARATOR

Thoracoscopic surgical ablation

Intervention Type PROCEDURE

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

Interventions

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Hybrid ablation

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

Intervention Type PROCEDURE

Thoracoscopic surgical ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhe Zheng, MD,PhD

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2016-828

Identifier Type: -

Identifier Source: org_study_id

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