Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation to Treat Chronic Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation in the Treatment of Persistent and Long-standing Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01716143
• Other study ID #: 2011-SR-014
• Status: Recruiting
• Phase: N/A
• First received: October 23, 2012
• Last updated: October 25, 2012
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Minglong Chen, MD
• Phone: 0086-25-6813-6965
• Email: chenminglong[@]njmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether left atrium substrate based ablation plus circumferential is effective in the treatment of persistent and long-standing atrial fibrillation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.

Exclusion Criteria:

1. Patients with paroxysmal AF (self-terminating episodes lasting < 7 day)

2. Patients who have had a previous AF ablation procedure

3. Pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• radiofrequency catheter ablation

Locations

Country	Name	City	State
China	Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 3,6,12,18 and 24 months after a single-ablation. procedure.		3 years	Yes
Secondary	The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation		December 31, 2012	Yes