Back to resultsClinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual ablation in based 3D CT of patient who diagnosed AF
conventional ablation based on physician's personal experience
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Virtual ablation, electrocardiography, electroanatomical mapping data
Eligibility Criteria
Inclusion Criteria:
- 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 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.
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
virtual simulation
conventional ablation
Arm Description
This 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.
The other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation.
Outcomes
Primary Outcome Measures
change of hospitalization rate
Secondary Outcome Measures
occurence of cardiovascular disease
recurrence of AF
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02171364
Brief Title
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 1, 2015 (Actual)
Study Completion Date
September 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Virtual ablation, electrocardiography, electroanatomical mapping data
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
virtual simulation
Arm Type
Experimental
Arm Description
This 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.
Arm Title
conventional ablation
Arm Type
Active Comparator
Arm Description
The other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation.
Intervention Type
Procedure
Intervention Name(s)
Virtual ablation in based 3D CT of patient who diagnosed AF
Intervention Type
Procedure
Intervention Name(s)
conventional ablation based on physician's personal experience
Primary Outcome Measure Information:
Title
change of hospitalization rate
Time Frame
1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.
Secondary Outcome Measure Information:
Title
occurence of cardiovascular disease
Time Frame
6 months
Title
recurrence of AF
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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.
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
31920716
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study
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