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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by The First Hospital of Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Youquan Wei, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01716143
First received: October 23, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: radiofrequency catheter ablation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation in the Treatment of Persistent and Long-standing Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by The First Hospital of Nanjing Medical University:

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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation [ Time Frame: December 31, 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 87
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
catheter ablation Procedure: radiofrequency catheter ablation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  1. Patients with paroxysmal AF (self-terminating episodes lasting < 7 day)
  2. Patients who have had a previous AF ablation procedure
  3. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716143

Contacts
Contact: Minglong Chen, MD 0086-25-6813-6965 chenminglong@njmu.edu.cn

Locations
China, Jiangsu
Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Minglong Chen, MD    0086-25-68136965    chenminglong@njmu.edu.cn   
Principal Investigator: Minglong Chen, MD         
Sponsors and Collaborators
The First Hospital of Nanjing Medical University
  More Information

No publications provided

Responsible Party: Youquan Wei, Clinical Investigator, The First Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01716143     History of Changes
Other Study ID Numbers: 2011-SR-014
Study First Received: October 23, 2012
Last Updated: October 25, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by The First Hospital of Nanjing Medical University:
atrial fibrillation
catheter ablation
Mapping

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014