Paroxysmal Supraventricular TachycardiaNCT04215640
Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes
A study testing Microfidelity (MIFI) catheter and Conventional ablation catheter in people with Paroxysmal Supraventricular Tachycardia, run by Yong Seog Oh at 1 site in South Korea.
Trial summary
Paroxysmal supraventricular tachycardia is treated with radiofrequency ablation recently. This procedure is performed by ablating slow pathway or accessory pathway using radiofrequency ablation catheter. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Paroxysmal Supraventricular Tachycardia
- What is being tested?
- Microfidelity (MIFI) catheter and Conventional ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2020to 1 Nov 2021
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are scheduled to undergo radiofrequency ablation for paroxysmal supraventricular tachycardia or WPW syndrome with atrial fibrillation
- Give written informed consent for the study
Who cannot join
- Unable to induce supraventricular tachycardia during electrophysiologic study.
- Cognitive impairment to understand study procedure
Trial locations and contacts
1 site in 1 country.
About this study
Paroxysmal supraventricular tachycardia is treated with radiofrequency ablation recently. This procedure is performed by ablating slow pathway or accessory pathway using radiofrequency ablation catheter. Recently developed mirofidelity (MIFI) catheter has mini-electrodes that can record local eletrogram with higher resolution. We aimed to investigate the efficacy of MIFI catheter in the ablation of paroxysmal supraventricular tachycardia compared to conventional radiofrequency ablation catheter. Enrolled patients undergo conventional electrophysiologic study. Patients with sustained supraventricular tachycardia during the study are randomized to either study group or control group. Radiofrequency ablation is performed using MIFI catheter in the study group, and conventional catheter (Blazer II) in the control group. The study endpoints are recorded immediately after ablation and there is no additional follow up or management after procedure.
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Being tested
- Microfidelity (MIFI) catheter, Conventional ablation catheter
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfidelity (MIFI) catheterDevice
Patients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Microfidelity (MIFI) catheter equipped with mini-electrodes will be used for ablation in the MIFI group.
Conventional ablation catheterDevice
Patients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Blazer II radiofrequency ablation catheter will be used for ablation in the control group.
| Study group | Role | What they receive |
|---|---|---|
| MIFI group | Experimental | Patients in the MIFI group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using microfidelity (MIFI) catheter. Receives: Device: Microfidelity (MIFI) catheter |
| Control | Active comparator | Patients in the control group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using conventional ablation catheter (Blazer II). Receives: Device: Conventional ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
RF time (seconds) to successful ablation
For AVNRT, the time (seconds) from the beginning of radiofrequency ablation to the emergence of junctional rhythm For AVRT, the time (seconds) from the beginning of radiofrequency ablation to the accessory pathway block
Measured: At the end of radiofrequency ablation procedure
RF application number
Number of radiofrequency ablation attempt to successful ablation
Measured: At the end of radiofrequency ablation procedure
Secondary outcomes (2)
Total ablation time (seconds)
Total time of radiofrequency energy delivery
Measured: At the end of radiofrequency ablation procedure
Presence of either acute reconnection or reinduction
Acute accessory pathway reconnection or supraventricular tachycardia reinduction after ablation
Measured: At the end of radiofrequency ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start13 Jan 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
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 Supraventricular TachycardiaStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Seog Oh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yong Seog Oh, Seoul St. Mary's Hospital
- Investigators
- Yong-Seog Oh, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215640
- Sponsor's protocol ID
- XC19DEDI0078K
- Status last verified
- Nov 2021
- First submitted
- 30 Dec 2019
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD would be provided with an appropriate request from other investigators.
Publications
Choi Y, Kim SH, Kim H, Park JW, Ha YW, Hwang Y, Kim JH, Jang SW, Oh YS. The advantage of the mini-electrode-equipped catheter for the radiofrequency ablation of paroxysmal supraventricular tachycardia. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2164-2171. doi: 10.1111/jce.15639. Epub 2022 Aug 24.
PubMed 35924472
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes
- ClinicalTrials.gov ID
- NCT04215640
- Acronym / sponsor ID
- XC19DEDI0078K
- Conditions
- Paroxysmal Supraventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Yong Seog OhUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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.
Paroxysmal supraventricular tachycardia is treated with radiofrequency ablation recently. This procedure is performed by ablating slow pathway or accessory pathway using radiofrequency ablation catheter. Recently developed mirofidelity (MIFI) catheter has mini-electrodes that can record local eletrogram with higher resolution. We aimed to investigate the efficacy of MIFI catheter in the ablation of paroxysmal supraventricular tachycardia compared to conventional radiofrequency ablation catheter. Enrolled patients undergo conventional electrophysiologic study. Patients with sustained supraventricular tachycardia during the study are randomized to either study group or control group. Radiofrequency ablation is performed using MIFI catheter in the study group, and conventional catheter (Blazer II) in the control group. The study endpoints are recorded immediately after ablation and there is no additional follow up or management after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIFI group | Experimental | Device: Microfidelity (MIFI) catheterPatients in the MIFI group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using microfidelity (MIFI) catheter. |
| Control | Active comparator | Device: Conventional ablation catheterPatients in the control group receive standard radiofrequency ablation procedure for the supraventricular tachycardia using conventional ablation catheter (Blazer II). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are scheduled to undergo radiofrequency ablation for paroxysmal supraventricular tachycardia or WPW syndrome with atrial fibrillation
- Give written informed consent for the study
Key exclusion criteria (2 listed)
- Unable to induce supraventricular tachycardia during electrophysiologic study.
- Cognitive impairment to understand study procedure
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 |
|---|---|---|
| Microfidelity (MIFI) catheterPatients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Microfidelity (MIFI) catheter equipped with mini-electrodes will be used for ablation in the MIFI group. | Device | MIFI group |
| Conventional ablation catheterPatients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Blazer II radiofrequency ablation catheter will be used for ablation in the control group. | Device | Control |
Primary outcome
RF time (seconds) to successful ablation
Time frame: At the end of radiofrequency ablation procedure
For AVNRT, the time (seconds) from the beginning of radiofrequency ablation to the emergence of junctional rhythm For AVRT, the time (seconds) from the beginning of radiofrequency ablation to the accessory pathway block
RF application number
Time frame: At the end of radiofrequency ablation procedure
Number of radiofrequency ablation attempt to successful ablation
2 secondary outcomes
Total ablation time (seconds)
Time frame: At the end of radiofrequency ablation procedure
Presence of either acute reconnection or reinduction
Time frame: At the end of radiofrequency ablation procedure
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 2 Nov 2021.
- Derived from this study: PubMed 35924472Choi Y, Kim SH, Kim H, Park JW, Ha YW, Hwang Y, Kim JH, Jang SW, Oh YS. The advantage of the mini-electrode-equipped catheter for the radiofrequency ablation of paroxysmal supraventricular tachycardia. J Cardiovasc Electrophysiol. 2022 Oct;33(10):2164-2171. doi: 10.1111/jce.15639. Epub 2022 Aug 24.
- Individual participant dataSharing planned: No. IPD would be provided with an appropriate request from other investigators.
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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. This study is not recruiting at the moment.
Yong-Seog Oh principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microfidelity (MIFI) catheter and Conventional ablation catheter in people with Paroxysmal Supraventricular Tachycardia, run by Yong Seog Oh 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 2 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 2 Nov 2021. 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?
RF time (seconds) to successful ablation (time frame: At the end of radiofrequency ablation procedure). 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 NCT04215640, 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 2 Nov 2021.