Actively Recruiting
Led by Yonsei University · Updated on 2023-01-03
110
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating treatments for patients with paroxysmal atrial fibrillation, a type of irregular heartbeat. This study compares traditional catheter ablation guided by a physician's experience with a new method that uses a 3D computer model of the patient's 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 physician's 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
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 1 location
1
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea, 120-752
Actively Recruiting
H
Hui-Nam Pak
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Young Choi, Byounghyun Lim, Song-Yi Yang...
https://pubmed.ncbi.nlm.nih.gov/35927040