Paroxysmal Atrial FibrillationCUVIA-AF IINCT02558699
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
A study testing physician's personal experience and Virtual rotor mapping in people with Paroxysmal Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- physician's personal experience and Virtual rotor mapping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
Hui-Nam Pak, M.D., Ph.D., 82-2-2228-8459, hnpak@yuhs.ac
About this study
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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- physician's personal experience, Virtual rotor mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physician's personal experienceProcedure or surgery
physician's personal experience
Virtual rotor mappingProcedure or surgery
Virtual rotor mapping
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | Group operating the atrial fibrillation by physician's personal experience, not by virtual simulation. Receives: Procedure: physician's personal experience |
| 3D atrial computer model | Experimental | Group choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape. Receives: Procedure: Virtual rotor mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
Measured: 18 months
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure
Measured: 24 months
Secondary outcomes (3)
Major complication related procedure : Complication of hemorrhagic and embolic
Measured: 24 months
Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure
Measured: 24 months
Procedure time and Radiofrequency ablation time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start24 Aug 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558699
- Sponsor's protocol ID
- 4-2015-0646
- Acronym
- CUVIA-AF II
- Status last verified
- Dec 2022
- First submitted
- 23 Sep 2015
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35927040
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
- ClinicalTrials.gov ID
- NCT02558699
- Acronym / sponsor ID
- CUVIA-AF II / 4-2015-0646
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Procedure: physician's personal experienceGroup operating the atrial fibrillation by physician's personal experience, not by virtual simulation. |
| 3D atrial computer model | Experimental | Procedure: Virtual rotor mappingGroup choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physician's personal experiencephysician's personal experience | Procedure or surgery | conventional group |
| Virtual rotor mappingVirtual rotor mapping | Procedure or surgery | 3D atrial computer model |
Primary outcome
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
Time frame: 18 months
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure
Time frame: 24 months
3 secondary outcomes
Major complication related procedure : Complication of hemorrhagic and embolic
Time frame: 24 months
Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure
Time frame: 24 months
Procedure time and Radiofrequency ablation time
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Derived from this study: PubMed 35927040Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physician's personal experience and Virtual rotor mapping in people with Paroxysmal Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Nam Pak (82-2-2228-8459, hnpak@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02558699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.