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

Keimyung University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: AF ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03989726

DSMCEP_PHS_003

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

High density voltage and fractionation map guided group

Experimental group

Description:

* 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.

Treatment:

Procedure: AF ablation

Circumferential PV isolation

Active Comparator group

Description:

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.

Treatment:

Procedure: AF ablation