Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study
1 other identifier
interventional
40
1 country
1
Brief Summary
Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease 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 test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Aug 2014
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMarch 18, 2019
March 1, 2019
1.1 years
June 19, 2014
March 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of hospitalization rate
1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.
Secondary Outcomes (2)
occurence of cardiovascular disease
6 months
recurrence of AF
6 months
Study Arms (2)
virtual simulation
EXPERIMENTALThis intervention group is to choose the best effective method operation to patients by simulating 3D atrial computer model which consider patient's heart size and shape.
conventional ablation
ACTIVE COMPARATORThe other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.
You may not qualify if:
- AF patients who have severe heart deformations or blood problems.
- The patients who had been performed catheter ablation of atrial ablation.
- The patients who missed out to recording of 3D CT, echo and electrocardiography.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
Related Publications (1)
Kim IS, Lim B, Shim J, Hwang M, Yu HT, Kim TH, Uhm JS, Kim SH, Joung B, On YK, Oh S, Oh YS, Nam GB, Lee MH, Shim EB, Kim YH, Pak HN; CUVIA-AF1 Investigators. Clinical Usefulness of Computational Modeling-Guided Persistent Atrial Fibrillation Ablation: Updated Outcome of Multicenter Randomized Study. Front Physiol. 2019 Dec 17;10:1512. doi: 10.3389/fphys.2019.01512. eCollection 2019.
PMID: 31920716DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2014
First Posted
June 24, 2014
Study Start
August 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 18, 2019
Record last verified: 2019-03