NCT03708471

Brief Summary

Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it. This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

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

March 4, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

4.3 years

First QC Date

October 14, 2018

Last Update Submit

February 10, 2020

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationHybrid ablationSurgical ablation

Outcome Measures

Primary Outcomes (1)

  • Atrial tachyarrhythmia recurrence

    Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.

    24 months after blanking-period.

Secondary Outcomes (2)

  • Systemic atrial embolism

    24 months after blanking-period.

  • Left atrial thrombus

    At 3months, 6months, 12months, 18months, 24months after intervention.

Study Arms (2)

Two-stage hybrid abltaion

EXPERIMENTAL

After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control.

Procedure: Hybrid ablation

Thoracosopic surgical ablation

ACTIVE COMPARATOR

After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control.

Procedure: Thoracoscopic surgical ablation

Interventions

Hybrid ablationPROCEDURE

This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.

Two-stage hybrid abltaion
Thoracoscopic surgical ablationPROCEDURE

This intervention including thoracoscopic surgical ablation and cardiovascular risk control.

Thoracosopic surgical ablation

Eligibility Criteria

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

You may qualify if:

  • Older than 18 years old.
  • Nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively.
  • Written informed consent

You may not qualify if:

  • Secondary atrial fibrillation caused by other reversible diseases.
  • Left atrial diameter \>55mm confrimed by Transthoracic echocardiography.
  • Intracardial mass or thrombus.
  • Previous cardiac surgery.
  • Uncontrolled heart failure or LVEF less than 30%.
  • Severe chest wall deformity.
  • Possibly pleural adhesion or pericardial adhesion caused by previous thoracic surgery, tuberculosis or constrictive pericarditis.
  • Severe comorbidities (e.g. severe CAD, severe renal failure, severe liver failure).
  • Life expectancy less than 2 years (e.g. patients with MODS or cancer)
  • Unsuitable for radiation exposure (e.g. pregnancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Huiming Guo, MD, PhD

CONTACT

+86 13609089789guohuiming@163.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of adult cardiac surgery

Study Record Dates

First Submitted

October 14, 2018

First Posted

October 17, 2018

Study Start

March 4, 2018

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

CN(1)