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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radiofrequency catheter ablation
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, Mapping

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Cardiology, the First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

catheter ablation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation

Full Information

First Posted
October 23, 2012
Last Updated
October 25, 2012
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01716143
Brief Title
Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation to Treat Chronic Atrial Fibrillation
Official Title
Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation in the Treatment of Persistent and Long-standing Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, Mapping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
catheter ablation
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
radiofrequency catheter ablation
Primary Outcome Measure Information:
Title
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation
Time Frame
December 31, 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Patients with paroxysmal AF (self-terminating episodes lasting < 7 day) Patients who have had a previous AF ablation procedure Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minglong Chen, MD
Phone
0086-25-6813-6965
Email
chenminglong@njmu.edu.cn
Facility Information:
Facility Name
Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minglong Chen, MD
Phone
0086-25-68136965
Email
chenminglong@njmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Minglong Chen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26857907
Citation
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.
Results Reference
derived

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

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