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Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
epicardial radiofrequency ablation
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, radiofrequency, totally thoracoscope, epicardial

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patients with atrial fibrillation

Exclusion Criteria:

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

Sites / Locations

  • Institute of Cardiovascular Surgery, Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ablation

Arm Description

patients with atrial fibrillation underwent radiofrequency ablation with totally thoracoscope.

Outcomes

Primary Outcome Measures

Electrocardiography

Secondary Outcome Measures

Full Information

First Posted
January 14, 2009
Last Updated
February 12, 2009
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00844584
Brief Title
Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope
Official Title
Clinical Study of Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, radiofrequency, totally thoracoscope, epicardial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ablation
Arm Type
Other
Arm Description
patients with atrial fibrillation underwent radiofrequency ablation with totally thoracoscope.
Intervention Type
Procedure
Intervention Name(s)
epicardial radiofrequency ablation
Other Intervention Name(s)
radiofrequency ablation
Intervention Description
epicardial radiofrequency ablation to treat atrial fibrillation under totally thoracoscope
Primary Outcome Measure Information:
Title
Electrocardiography
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patients with atrial fibrillation Exclusion Criteria: Patients with hemostasis defects patients can not endure general anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenxiao Jin, MD
Phone
86-29-84771022
Email
jinzx10262@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Dinghua Yi, MD
Phone
86-29-84775307
Email
yidinghua@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinghua Yi, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Cardiovascular Surgery, Xijing Hospital
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinghua Yi, MD
Phone
86-29-84775307
Email
yidinghua@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Zhenxiao Jin, MD
First Name & Middle Initial & Last Name & Degree
Xuezeng Xu, MD
First Name & Middle Initial & Last Name & Degree
Shiqiang Yu, MD

12. IPD Sharing Statement

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Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope

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