Using virtual drug testing to improve treatment for recurrent atrial fibrillation after catheter ablation
Clinical Usefulness of Virtual Antiarrhythmic Drug Test in Patients With Recurred AF After Catheter Ablation(CUVIA-AF3)
This study is testing if a new virtual system for choosing heart medications can help people with recurring atrial fibrillation feel better after their catheter procedure compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04223310 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of a virtual antiarrhythmic drug (AAD) testing system for patients who experience recurrent atrial fibrillation (AF) after catheter ablation. It involves a prospective randomized design where participants will be assigned to either a virtual AAD test group or an empirical AAD group. The study will monitor patients' heart rhythms using Holter monitoring and ECGs at various intervals to assess the efficacy of the AADs selected through computer modeling versus traditional methods. The goal is to determine if personalized AAD selection can lead to better outcomes in managing recurrent AF.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 to 80 who have experienced recurrent atrial fibrillation after catheter ablation and are suitable for AAD therapy.
Not a fit: Patients with permanent atrial fibrillation or significant structural heart disease are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment options for patients with recurrent atrial fibrillation, potentially reducing recurrence rates and improving quality of life.
How similar studies have performed: While the use of virtual modeling for drug efficacy evaluation is a novel approach, similar studies have shown promise in improving treatment outcomes for various conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Severance Cardiovascular Hospital, Yonsei University Health System — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hui-Nam Park
- Email: hnpak@yuhs.ac
- Phone: 82-2-2228-8459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.