Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: physician's personal experience, Virtual rotor mapping.
- Who it may be relevant to
- Registry conditions: Paroxysmal Atrial Fibrillation. Basic parameters: 19 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Procedure physician's personal experience
physician's personal experience - Procedure Virtual rotor mapping
Virtual rotor mapping
Primary outcome measures
- Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months [Time frame: 18 months]
- Rate of mortality, incidence of cerebral infarction and hospitalization after procedure [Time frame: 24 months]
Secondary outcome measures (3)
- Major complication related procedure : Complication of hemorrhagic and embolic [Time frame: 24 months]
- Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure [Time frame: 24 months]
- Procedure time and Radiofrequency ablation time [Time frame: 24 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Severance Cardiovascular Hospital, Yonsei University Health System — Seoul
Publications
- Choi Y, Lim B, Yang SY, Yang SH, Kwon OS, Kim D, Kim YG, Park JW, Yu HT, Kim TH, Yang PS, Uhm JS, Shim J, Kim SH, Sung JH, Choi JI, Joung B, Lee MH, Kim YH, Oh YS, Pak HN; CUVIA-REGAB Investigators. Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation Targeting Restitution Parameter-Guided Catheter Ablation: CUVIA-REGAB Prospective Randomized Study. Korean Circ J PMID 35927040
Identifiers
NCT: NCT02558699 · 4-2015-0646