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

NCT04223310 | Unknown DMC

• 1 other identifier: 4-2019-1049
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Recurred Atrial Fibrillation After AFCA; AF catheter ablation; Virtual antiarrhythmic drug test

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (25)

• Comparison of cardioversion frequency

  At 2 months after medication

• Comparison of cardioversion frequency

  At 6 months after medication

• Comparison of cardioversion frequency

  At 12 months after medication

• Comparison of cardioversion frequency

  At 18 months after medication

• Comparison of cardioversion frequency

  At 24 months after medication

Study Arms (2)

Virtual AAD TEST group

EXPERIMENTAL

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.

Drug: Virtual AAD TEST group

Empirical AAD group

ACTIVE COMPARATOR

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.

Drug: Empirical AAD group

Interventions

Virtual AAD TEST group DRUG

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.

Virtual AAD TEST group

Empirical AAD group DRUG

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.

Empirical AAD group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Permanent AF Patients
• AF associated with significant structural heart disease with severe anomaly or hemodynamic effects
• Patients expected to have serious side effects when using AAD due to sinus node dysfunction
• Severe liver or renal failure
• Patients with past cardiac surgery history
• Patients who are unable to oral medication or have electrolyte abnormalities
• Patients with active internal bleeding
• Contraindications for anticoagulant therapy (administered anticoagulant drugs to prevent cerebral infarction) or AAD
• Valvular AF (mitral stenosis\> grade 2, mechanical valve, mitral valve repair)
• Severe concomitant illness
• Patients expected to live for less than one year
• Patients with drug or alcoholism
• Those who cannot read the agreement (literacy, foreigners, etc.)
• Patients judged to be inappropriate for participation in clinical trials by other researchers' judgment

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hui-Nam Park

CONTACT

82-2-2228-8459; hnpak@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 10, 2020
• Study Start: June 13, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

KR (1)