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

NCT01716143 — Not applicable, Unknown, 87 participants, The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01716143
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	87 (Estimated)
Sponsor	The First Affiliated Hospital with Nanjing Medical University (Other)
Conditions	Atrial Fibrillation
Interventions	radiofrequency catheter ablation (Procedure)
Dates	start 2010-03-01, primary completion 2012-06-01, completion 2012-12-01 (estimated), first posted 2012-10-29, last updated 2012-10-29
Locations	1 site in China

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
catheter ablation	Other	Procedure: radiofrequency catheter ablation

radiofrequency catheter ablation (Procedure)

+Outcome measures

Primary outcomes

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 outcomes

The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation [December 31, 2012]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University	Nanjing, Jiangsu	China	Recruiting

+Publications

Results publication: Yang G, Yang B, Wei Y, Zhang F, Ju W, Chen H, Li M, Gu K, Lin Y, Wang B, Cao K, Kojodjojo P, Chen M. Catheter Ablation of Nonparoxysmal Atrial Fibrillation Using Electrophysiologically Guided Substrate Modification During Sinus Rhythm After Pulmonary Vein Isolation. Circ Arrhythm Electrophysiol. 2016 Feb;9(2):e003382. doi: 10.1161/CIRCEP.115.003382. PMID 26857907