NCT00844584

Brief Summary

Atrial fibrillation (AF) is a common supraventricular arrhythmia, the incidence of which increases with age. The aim of treatment of atrial fibrillation is to restore sinus rhythm and return the heart to atrioventricular synchrony, avoiding the risk of thromboembolism. The fact that pharmacological therapy of AF is at best 50% effective has led to a search for surgical approaches over the last 20 years. Maze procedure was a classic method to treat AF. However, it is such a complex procedure that very few surgeons have adopted it. A few minimally invasive procedures to create transmural lesions which mimic MAZE procedure have been introduced. One of the mostly favored methods is catheter-based radiofrequency ablation, another one is video assisted epicardial radiofrequency ablation through small thoracic incisions in operating room. Recently, we invented an epicardial radiofrequency ablation method under totally thoracoscope, which further minimized the surgery trauma and increased the cosmetic effect.

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
20

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 16, 2009

Status Verified

January 1, 2009

Enrollment Period

2.2 years

First QC Date

January 14, 2009

Last Update Submit

February 12, 2009

Conditions

Keywords

Atrial fibrillationradiofrequencytotally thoracoscopeepicardial

Outcome Measures

Primary Outcomes (1)

  • Electrocardiography

    2 years

Study Arms (1)

ablation

OTHER

patients with atrial fibrillation underwent radiofrequency ablation with totally thoracoscope.

Procedure: epicardial radiofrequency ablation

Interventions

epicardial radiofrequency ablation to treat atrial fibrillation under totally thoracoscope

Also known as: radiofrequency ablation
ablation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patients with atrial fibrillation

You may not qualify if:

  • Patients with hemostasis defects
  • patients can not endure general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Cardiovascular Surgery, Xijing Hospital

Xi'an, Shannxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Dinghua Yi, MD

    Xijing Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2009

First Posted

February 16, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

February 16, 2009

Record last verified: 2009-01

Locations