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

NCT03989726 | Unknown

• 1 other identifier: DSMCEP_PHS_003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Free from atrial arrhythmia at 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.

  12 months

Secondary Outcomes (3)

• Acute AF termination rate during the procedure

  During the procedure

• Complication rate

  12 months

• Total procedure time, ablation time, fluoroscopy time

  12 months

Study Arms (2)

High density voltage and fractionation map guided group

EXPERIMENTAL

* 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.

Procedure: AF ablation

Circumferential PV isolation

ACTIVE COMPARATOR

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.

Procedure: AF ablation

Interventions

AF ablation PROCEDURE

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

Circumferential PV isolation; High density voltage and fractionation map guided group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Abbott: collaborator

Study Sites (1)

Keimyung University Dongsan Hospital

Daegu, 42602, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hyoung-Seob Park, MD

CONTACT

+82-53-258-7725; drparkgyver@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: May 31, 2021
• Last Updated: August 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)