Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope

Atrial Fibrillation Clinical Trial

Official title:

Clinical Study of Radiofrequency Ablation of Atrial Fibrillation Under Totally Thoracoscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00844584
• Other study ID #: xinzangwaike0001
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2009
• Last updated: February 12, 2009
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: January 2009
• Source: Xijing Hospital
• Contact: Zhenxiao Jin, MD
• Phone: 86-29-84771022
• Email: jinzx10262[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Any patients with atrial fibrillation

Exclusion Criteria:

• Patients with hemostasis defects

• patients can not endure general anesthesia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• epicardial radiofrequency ablation
epicardial radiofrequency ablation to treat atrial fibrillation under totally thoracoscope

Locations

Country	Name	City	State
China	Institute of Cardiovascular Surgery, Xijing Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrocardiography		2 years	No