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

October 25, 2012 updated by: Youquan Wei, The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Minglong Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: catheter ablation
Procedure: radiofrequency catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation
Time Frame: December 31, 2012
December 31, 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-SR-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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