Evaluating Virtual Rotor Mapping to Guide Catheter Ablation for Treating Paroxysmal Atrial Fibrillation in Adults
Led by Yonsei University · Updated on 2023-01-03
110
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with paroxysmal atrial fibrillation, a type of irregular heartbeat. This study compares traditional catheter ablation guided by a physicians experience with a new method that uses a 3D computer model of the patients heart to guide virtual rotor mapping and additional ablation. The goal is to see if the new method reduces the chance of atrial fibrillation returning after treatment.
Participants will be randomly assigned to one of two groups. One group receives catheter ablation based on the physicians personal experience without computer simulation. The other group receives ablation guided by virtual rotor mapping from a patient-specific 3D atrial model, which accounts for individual heart size and shape. Both groups undergo pulmonary vein isolation, with the experimental group receiving extra rotor ablation based on the simulation.
During the study, participants will be monitored for up to 24 months after the procedure. Researchers will assess the recurrence of atrial fibrillation over 18 months, as well as rates of mortality, stroke, and hospitalizations over 24 months. They will also track complications such as bleeding, pericardial effusion, and blood transfusion needs. Procedure time and radiofrequency ablation time will be recorded to evaluate treatment efficiency.
CONDITIONS
Brief Title
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
Research Team
H
Hui-Nam Pak
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Diagnosis of atrial fibrillation with catheter ablation due to uncontrolled pulse rate despite anti-arrhythmic drug therapy
You will not qualify if you...
Severe heart deformities or vascular disease
Kidney disease with estimated glomerular filtration rate (eGFR) less than 30 mL/min
Previous catheter ablation of atrial fibrillation or MAZE procedure
Missing records of 3D CT, echocardiography, or electrocardiography
History of major hemorrhagic complications
History of ischemic cerebral infarction more than twice
High risk of ischemic cerebral infarction with CHA2DS2-VASc Score greater than 5
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Procedure day
Participants undergo catheter ablation for atrial fibrillation, guided either by physician's personal experience or virtual rotor mapping using a 3D atrial computer model tailored to their heart size and shape.
1 procedure visit (in-person)
Follow-up
Duration - Up to 24 months
Participants are monitored for recurrence of atrial fibrillation, complications, and other health outcomes after the catheter ablation procedure.
Regular follow-up visits over 24 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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