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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02558699
Acronym
CUVIA-AF II
Enrollment
110
Registered
2015-09-24
Start date
2018-08-24
Completion date
2027-12-31
Last updated
2023-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Brief 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.

Interventions

PROCEDUREphysician's personal experience

physician's personal experience

PROCEDUREVirtual rotor mapping

Virtual rotor mapping

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months18 months
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure24 months

Secondary

MeasureTime frame
Major complication related procedure : Complication of hemorrhagic and embolic24 months
Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure24 months
Procedure time and Radiofrequency ablation time24 months

Countries

South Korea

Contacts

Primary ContactHui-Nam Pak
hnpak@yuhs.ac82-2-2228-8459

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026