AF Ablation Based on High Density Voltage Mapping and CFAE

NCT ID: NCT03046043

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-12-23

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Low-Voltage & CFAE guided ablation

• Pulmonary isolation will be performed
• Complex fractionated atrial electrogram(CFAE) and voltage mapping will be performed if atrial fibrillation the patient is still in atrial fibrillation after pulmonary vein isolation
• CFAE and voltage mapping will be performed simultaneously using small electrode Pentaray® Catheter with CARTO®3 MEM version or CARTO®3 CONFIDENSE™
• Automatic characterization of CFAE signals will be performed with an CARTO® CFAE software module.
• CFAE areas within low voltage zone in the left atrium should be targeted first. If atrial fibrillation persist after left atrial ablation, target areas in the right atrium should be mapped and ablated. (Low-Voltage & CFAE guided ablation)

Group Type: EXPERIMENTAL

pulmonary vein isolation

Intervention Type: PROCEDURE

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

Low-Voltage & CFAE guided ablation

Intervention Type: 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.

PV Isolation Only

• Pulmonary vein isolation will be performed.
• Electrical cardioversion to sinus rhythm will be performed if the patient is still in atrial fibrillation after pulmonary vein isolation.

Group Type: ACTIVE_COMPARATOR

pulmonary vein isolation

Intervention Type: PROCEDURE

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

Interventions

pulmonary vein isolation

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

Intervention Type: PROCEDURE

Low-Voltage & CFAE guided ablation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age over 20 years old and under 80 years old

2. Patients with non-valvular atrial fibrillation

3. Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks

4. Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them

5. Patients who are available of follow-up at least for more than three months after catheter ablation

Exclusion Criteria

1. Patients unsuitable for catheter ablation because the size of left atrium is over 6.0 cm

2. Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.

3. Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation

4. Patients in the subject group vulnerable to clinical study

5. Patients who had undergone a prior catheter ablation for atrial fibrillation

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hyoung-Seob Park

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyoung-Seob Park, MD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Locations

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Countries

South Korea

Other Identifiers

DSMCEP_PHS_002

Identifier Type: -

Identifier Source: org_study_id