Efficacy of High Density Voltage and Fractionation Map Guided Ablation in Patients With Atrial Fibrillation

NCT ID: NCT03989726

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-05-31

Brief Summary

The purpose of this study is to evaluate the efficacy of high density voltage and fractionation map guided ablation compared to anatomy-based circumferential pulmonary vein Isolation in patients with atrial fibrillation

Detailed Description

In this study, a test group includes those who undergoing atrial fibrillation(AF) ablation guided by high density voltage and fractionation map. A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential pulmonary vein (PV) isolation.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High density voltage and fractionation map guided group

• Complex fractionated atrial electrogram (CFAE), voltage and fractionation map will be performed with a multielectrode mapping catheter.
• The mapping should be performed in AF.
• First, low-voltage zone is defined as an area with bipolar peak-to-peak voltage amplitudes < 0.5mV.
• A voltage-map guided segmental PV isolation is performed. Radiofrequency energy is applied in the antral regions of the PVs. High voltage zone over 0.5mV in the antral region is targeted. IF PV isolation in not achieved by voltage-guided segmental ablation, additional Lasso catheter guided segmental antral ablation is performed.
• Radiofrequency energy is delivered at target sites for 15-30 sec guided by contact force, lesion size index (LSI) and local electrogram elimination.
• If the patient is still in AF after PV isolation, additional fractionation map guided ablation is performed. The fractionation area within low voltage area (<0.5mV) should be targeted.

Group Type: EXPERIMENTAL

AF ablation

Intervention Type: PROCEDURE

AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation

Circumferential PV isolation

A control group will be chosen from database of patients who underwent AF ablation between 2018-2019. A control group includes the same number of consecutive patients who underwent anatomy-based circumferential PV isolation.

Group Type: ACTIVE_COMPARATOR

AF ablation

Intervention Type: PROCEDURE

AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation

Interventions

AF ablation

AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation

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 AF 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

Abbott

INDUSTRY

Sponsor Role: collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyoung-Seob Park, MD

Role: CONTACT

drparkgyver@gmail.com

+82-53-258-7725

Facility Contacts

Hyoung-Seob Park, MD

Role: primary

drparkgyver@gmail.com

82532507473

Other Identifiers

DSMCEP_PHS_003

Identifier Type: -

Identifier Source: org_study_id