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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: radiofrequency catheter ablation

• Registration Number: NCT01716143
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-06
• Status Verified: 2012-10
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-25
• Last Update Submitted: 2012-10-25
• Study First Posted: 2012-10-29
• Last Update Posted: 2012-10-29
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
catheter ablation	radiofrequency catheter ablation	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation	December 31, 2012

Trial Locations

Locations (1)

Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China