Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation

Paroxysmal Atrial Fibrillation Clinical Trial

— CUVIA-AF II  

Official title:

Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02558699
• Other study ID #: 4-2015-0646
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2022
• Source: Yonsei University
• Contact: Hui-Nam Pak
• Phone: 82-2-2228-8459
• Email: hnpak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal atrial fibrillation. In order to reduce the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will conduct virtual rotor mapping in the patient specific atrial model. Then, the investigators will compare the clinical outcome of conventional circumferential pulmonary vein isolation and additional rotor ablation guided by virtual rotor mapping.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• AF patient age 19~80

• Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

Exclusion Criteria:

• AF patients who have severe heart deformations or vascular disease.

• The patient who have renal disease of eGFR<30mL/min

• The patients who had been performed catheter ablation of atrial ablation and MAZE.

• The patients who missed out to recording of 3D CT, echo and electrocardiography.

• the patient have experienced major hemorrhagic complication

• The patient have experienced ischemic cerebral infarction more 2 times

• The patient who have risk of ischemic cerebral infarction (CHA2DS2-VASc Score >5)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• physician's personal experience
physician's personal experience
• Virtual rotor mapping
Virtual rotor mapping

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	Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months		18 months
Primary	Rate of mortality, incidence of cerebral infarction and hospitalization after procedure		24 months
Secondary	Major complication related procedure : Complication of hemorrhagic and embolic		24 months
Secondary	Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure		24 months
Secondary	Procedure time and Radiofrequency ablation time		24 months