Skip to main content
Clinical Trials/NCT03046043
NCT03046043
Completed
Not Applicable

Ablation of Persistent Atrial Fibrillation Based on High Density Voltage Mapping and Complex Fractionated Atrial Electrogram

Keimyung University Dongsan Medical Center1 site in 1 country50 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Keimyung University Dongsan Medical Center
Enrollment
50
Locations
1
Primary Endpoint
Free from atrial arrhythmia at 12 months
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy of additional ablation targeting complex fractionated atrial electrogram area within low voltage zone identified by high resolution mapping in patients with persistent atrial fibrillation.

Detailed Description

Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each group. A test group includes those who undergoing ablation targeting low voltage areas which contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a control group includes who undergoing pulmonary vein isolation only.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
December 23, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyoung-Seob Park

Associate Professor

Keimyung University Dongsan Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age over 20 years old and under 80 years old
  • Patients with non-valvular atrial fibrillation
  • Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
  • Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
  • Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria

  • Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm
  • Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
  • Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
  • Patients in the subject group vulnerable to clinical study
  • Patients who had undergone a prior catheter ablation for atrial fibrillation

Outcomes

Primary Outcomes

Free from atrial arrhythmia at 12 months

Time Frame: 12 months

Freedom from any atrial arrhythmia lasting longer than 30 seconds during 1 year follow-up after single ablation with or without the use of antiarrhythmic medications with the exclusion of the 3-month blanking period.

Secondary Outcomes

  • Complication rate(12 months)
  • Total procedure time, ablation time and fluoroscopy time(12 months)

Study Sites (1)

Loading locations...

Similar Trials