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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223310
• Other study ID #: 4-2019-1049
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Yonsei University
• Contact: Hui-Nam Park
• Phone: 82-2-2228-8459
• Email: hnpak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A. Study design

1. Prospective randomization (Virtual AAD TEST group vs. Empirical AAD group )

2. Target number of subjects: 300 (150 per group)

3. Rhythm FU : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom)

4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines

5. All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate.

B. Progress and rhythm/ECG follow-up

1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management

2. Follow-up at 2 weeks, 2 months, and thereafter every 6-month after medication.

3. Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter after medication

4. If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.

C. Follow-up All the patients will be followed-up at 2 weeks, 2, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed 2months and every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy evaluation: clinical recurrence rate	Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms	At 2 months after medication
Primary	Efficacy evaluation: clinical recurrence rate	Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms	At 6months after medication
Primary	Efficacy evaluation: clinical recurrence rate	Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms	At 12 months after medication
Primary	Efficacy evaluation: clinical recurrence rate	Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms	At 18 months after medication
Primary	Efficacy evaluation: clinical recurrence rate	Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 year. Based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms	At 24months after medication
Primary	Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 2 months after medication
Primary	Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 6 months after mediation
Primary	Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 12 months after mediacation
Primary	Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 18 months after mediacation
Primary	Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 24 months after mediacation
Secondary	Comparison of cardioversion frequency	comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)	At 2 months after medication
Secondary	Comparison of cardioversion frequency	comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)	At 6 months after medication
Secondary	Comparison of cardioversion frequency	comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)	At 12 months after medication
Secondary	Comparison of cardioversion frequency	comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)	At 18 months after medication
Secondary	Comparison of cardioversion frequency	comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage)	At 24 months after medication
Secondary	re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 2 months after medication
Secondary	re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 6 months after medication
Secondary	re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 12 months after medication
Secondary	re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 18 months after medication
Secondary	re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 24months after medication
Secondary	Rate of re-hospitalization	Rate of re-hospitalization after medication	At 2 months after medication
Secondary	Rate of re-hospitalization	Rate of re-hospitalization after medication	At 6 months after medication
Secondary	Rate of re-hospitalization	Rate of re-hospitalization after medication	At 12 months after medication
Secondary	Rate of re-hospitalization	Rate of re-hospitalization after medication	At 18 months after medication
Secondary	Rate of re-hospitalization	Rate of re-hospitalization after medication	At 24 months after medication
Secondary	Frequency of drug complication	Frequency of drug complication after medication	At 2 months after medication
Secondary	Frequency of drug complication	Frequency of drug complication after medication	At 6 months after medication
Secondary	Frequency of drug complication	Frequency of drug complication after medication	At 12 months after medication
Secondary	Frequency of drug complication	Frequency of drug complication after medication	At 18 months after medication
Secondary	Frequency of drug complication	Frequency of drug complication after medication	At 24 months after medication
Secondary	Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 2 months after medication
Secondary	Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 6 months after medication
Secondary	Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 12 months after medication
Secondary	Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 18 months after medication
Secondary	Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 24 months after medication