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Clinical Usefulness of Virtual Antiarrhythmic Drug Test in Patients With Recurred AF After Catheter Ablation(CUVIA-AF3)

NCT04223310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-13

No results posted yet for this study

Summary

Catheter ablation for atrial fibrillation (AF) is an effective rhythm control method that shows superior rhythm outcome than antiarrhythmic drug (AAD) treatment in drug-resistant AF. However, AF catheter ablation still has a substantial recurrence rate.

The current AAD use guidelines for AF management focus on the safety of drug use. However, if the AAD efficacy evaluation system using computer modeling reflecting the individual anatomy, electrophysiology, and histological characteristics of patients is practical, it will help to select a more effective AAD type or dose.

The purpose of this study is to conduct a prospective randomized clinical study on the efficacy and safety of computer modeling for optimal AAD selection in patients with recurrent AF after catheter ablation. The investigator will evaluate the efficacy of AAD simulations by comparing virtual AAD effect guided therapy and empirical AAD use in patients with recurrent AF after AF catheterization.

The investigator will test the virtual AAD effects in the computer simulations integrated by cardiac images and 3D electrophysiological maps obtained during de novo AF ablation. The investigator will compare the effects of the most potent AAD selected by virtual AAD simulation with those of empirical AAD.

Conditions

Interventions

DRUG

Virtual AAD TEST group

1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure 2. Preselect drug with optimal antiarrhythmic effects in the patient. 3. Take an AAD selected by virtual AAD simulation in patients who recur AF after catheter resection 4. Drug selection should be decided according to the guidelines. 5. A follow-up of rhythm follow-up has to be conducted according to the above study design.

DRUG

Empirical AAD group

1. Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure 2. Selection of AAD based on the experience of the attending physician, independent of the results of the virtual AAD test in patients who recur AF after catheter resection 3. Drug selection should be decided according to the guidelines. 4. A follow-up of rhythm follow-up has to be conducted according to the above study design.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223310 on ClinicalTrials.gov