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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• The patients with 20\

⁃ 80 years old those recurred AF after catheter ablation

• Patients who are suitable for sinus rhythm conversion and maintenance using AAD medications

• Patients who had no history of serious side effects due to AAD medications before the procedure

Locations
Other Locations
Republic of Korea
Severance Cardiovascular Hospital, Yonsei University Health System
RECRUITING
Seoul
Contact Information
Primary
Hui-Nam Park
hnpak@yuhs.ac
82-2-2228-8459
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2024-12
Participants
Target number of participants: 300
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov

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