Atrial FibrillationNCT02171364
Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study
A study testing Virtual ablation in based 3D CT of patient who diagnosed AF and conventional ablation based on physician's personal experience in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Virtual ablation in based 3D CT of patient who diagnosed AF and conventional ablation based on physician's personal experience
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to 1 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Virtual ablation in based 3D CT of patient who diagnosed AF, conventional ablation based on physician's personal experience
- Keywords
- Atrial fibrillation, Virtual ablation, electrocardiography, electroanatomical mapping data
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual ablation in based 3D CT of patient who diagnosed AFProcedure or surgery
conventional ablation based on physician's personal experienceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| virtual simulation | Experimental | 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. Receives: Procedure: Virtual ablation in based 3D CT of patient who diagnosed AF |
| conventional ablation | Active comparator | The other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation. Receives: Procedure: conventional ablation based on physician's personal experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of hospitalization rate
Measured: 1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.
Secondary outcomes (2)
occurence of cardiovascular disease
Measured: 6 months
recurrence of AF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startAug 2014
- Primary completion1 Sep 2015
- Study completion1 Sep 2015
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 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171364
- Sponsor's protocol ID
- 4-2013-0536
- Status last verified
- Mar 2019
- First submitted
- 19 Jun 2014
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31920716
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. 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: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02171364
- Acronym / sponsor ID
- 4-2013-0536
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Virtual ablation, electrocardiography, electroanatomical mapping data
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 1 Sep 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 24 Jun 2014 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual simulation | Experimental | Procedure: Virtual ablation in based 3D CT of patient who diagnosed AFThis 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 comparator | Procedure: conventional ablation based on physician's personal experienceThe other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Virtual ablation in based 3D CT of patient who diagnosed AF | Procedure or surgery | virtual simulation |
| conventional ablation based on physician's personal experience | Procedure or surgery | conventional ablation |
Primary outcome
change of hospitalization rate
Time frame: 1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.
2 secondary outcomes
occurence of cardiovascular disease
Time frame: 6 months
recurrence of AF
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Derived from this study: PubMed 31920716Kim 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.
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Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual ablation in based 3D CT of patient who diagnosed AF and conventional ablation based on physician's personal experience in people with 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 18 Mar 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of hospitalization rate (time frame: 1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.). 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 NCT02171364, 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 18 Mar 2019.