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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Anti-Arrhythmia Agents

Criteria

Inclusion Criteria:

1. The patients with 20~80 years old those recurred AF after catheter ablation

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

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

Exclusion Criteria:

1. Permanent AF Patients

2. AF associated with significant structural heart disease with severe anomaly or hemodynamic effects

3. Patients expected to have serious side effects when using AAD due to sinus node dysfunction

4. Severe liver or renal failure

5. Patients with past cardiac surgery history

6. Patients who are unable to oral medication or have electrolyte abnormalities

7. Patients with active internal bleeding

8. Contraindications for anticoagulant therapy (administered anticoagulant drugs to prevent cerebral infarction) or AAD

9. Valvular AF (mitral stenosis> grade 2, mechanical valve, mitral valve repair)

10. Severe concomitant illness

11. Patients expected to live for less than one year

12. Patients with drug or alcoholism

13. Those who cannot read the agreement (literacy, foreigners, etc.)

14. Patients judged to be inappropriate for participation in clinical trials by other researchers' judgment