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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Virtual AAD TEST group; Drug: Empirical AAD group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui-Nam Park; Phone Number: 82-2-2228-8459; Email: hnpak@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Cardiovascular Hospital, Yonsei University Health System
    • Contact: Hui-Nam Pak, M.D., Ph.D.; Phone Number: 82-2-2228-8459; Email: hnpak@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 2 months after medication
Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 6 months after mediation
Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 12 months after mediacation
Safety evaluation: Major cardiovascular event rate after medication	Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage	At 18 months after mediacation
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 2 months after medication
re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 6 months after medication
re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 12 months after medication
re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 18 months after medication
re-ablation(RFCA) fequency	re-ablation(RFCA) fequency after medication.	At 24months after medication
Rate of re-hospitalization	Rate of re-hospitalization after medication	At 2 months after medication
Rate of re-hospitalization	Rate of re-hospitalization after medication	At 6 months after medication
Rate of re-hospitalization	Rate of re-hospitalization after medication	At 12 months after medication
Rate of re-hospitalization	Rate of re-hospitalization after medication	At 18 months after medication
Rate of re-hospitalization	Rate of re-hospitalization after medication	At 24 months after medication
Frequency of drug complication	Frequency of drug complication after medication	At 2 months after medication
Frequency of drug complication	Frequency of drug complication after medication	At 6 months after medication
Frequency of drug complication	Frequency of drug complication after medication	At 12 months after medication
Frequency of drug complication	Frequency of drug complication after medication	At 18 months after medication
Frequency of drug complication	Frequency of drug complication after medication	At 24 months after medication
Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 2 months after medication
Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 6 months after medication
Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 12 months after medication
Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 18 months after medication
Rate of discontinuation of medication	Rate of discontinuation of medication due to complication	At 24 months after medication
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Recurred Atrial Fibrillation After AFCA; AF catheter ablation; Virtual antiarrhythmic drug test
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 4-2019-1049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No