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Completed

NCT Number: NCT03046043

AF Ablation Based on High Density Voltage Mapping and CFAE

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary vein isolation

Procedure

pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein

Low-Voltage & CFAE guided ablation

Procedure

In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated.

Primary outcomes

  1. 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

  1. Complication rate

    Time frame: 12 months

    Compare complication rate between two groups

  2. Total procedure time, ablation time and fluoroscopy time

    Time frame: 12 months

    Compare total procedure time, ablation time and fluoroscopy time between two groups

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2017
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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