Back to resultsClinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation (CUVIA-AF II)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
physician's personal experience
Virtual rotor mapping
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
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)
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional group
3D atrial computer model
Arm Description
Group operating the atrial fibrillation by physician's personal experience, not by virtual simulation.
Group choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape.
Outcomes
Primary Outcome Measures
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure
Secondary Outcome Measures
Major complication related procedure : Complication of hemorrhagic and embolic
Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure
Procedure time and Radiofrequency ablation time
Full Information
NCT ID
NCT02558699
First Posted
September 23, 2015
Last Updated
December 28, 2022
Sponsor
Yonsei University
1. Study Identification
Unique Protocol Identification Number
NCT02558699
Brief Title
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
Acronym
CUVIA-AF II
Official Title
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
Group operating the atrial fibrillation by physician's personal experience, not by virtual simulation.
Arm Title
3D atrial computer model
Arm Type
Experimental
Arm Description
Group choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape.
Intervention Type
Procedure
Intervention Name(s)
physician's personal experience
Intervention Description
physician's personal experience
Intervention Type
Procedure
Intervention Name(s)
Virtual rotor mapping
Intervention Description
Virtual rotor mapping
Primary Outcome Measure Information:
Title
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
Time Frame
18 months
Title
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Major complication related procedure : Complication of hemorrhagic and embolic
Time Frame
24 months
Title
Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure
Time Frame
24 months
Title
Procedure time and Radiofrequency ablation time
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Nam Pak
Phone
82-2-2228-8459
Email
hnpak@yuhs.ac
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Nam Pak, M.D., Ph.D.
Phone
82-2-2228-8459
Email
hnpak@yuhs.ac
12. IPD Sharing Statement
Citations:
PubMed Identifier
35927040
Citation
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. 2022 Sep;52(9):699-711. doi: 10.4070/kcj.2022.0113. Epub 2022 Jul 11.
Results Reference
derived
Learn more about this trial
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
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