UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059700 |
|---|---|
| Receipt number | R000068216 |
| Scientific Title | Local Activation Time Velocity Vector-Guided Target Localization and First-site Success in Typical Atrioventricular Nodal Reentrant Tachycardia Cryoablation: A Prospective Study |
| Date of disclosure of the study information | 2025/11/08 |
| Last modified on | 2025/11/08 16:04:24 |
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Basic information
Public title
Local Activation Time Velocity Vector-Guided Target Localization and First-site Success in Typical Atrioventricular Nodal Reentrant Tachycardia Cryoablation: A Prospective Study
Acronym
LVV-Guided Target Localization and First-site Success in Typical AVNRT Cryoablation: A Prospective Study
Scientific Title
Local Activation Time Velocity Vector-Guided Target Localization and First-site Success in Typical Atrioventricular Nodal Reentrant Tachycardia Cryoablation: A Prospective Study
Scientific Title:Acronym
LVV-Guided Target Localization and First-site Success in Typical AVNRT Cryoablation: A Prospective Study
Region
| Japan |
Condition
Condition
Typical atrioventricular nodal reentrant tachycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the proportion of cases in which noninducibility of typical atrioventricular nodal reentrant tachycardia is achieved within the target region (LVV hot-spot) identified using Local Activation Time Velocity Vectors (LVV), referred to as the first-site success rate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of cases in which non-inducibility of tachycardia is achieved by cryoablation performed only within the target area identified by Local Activation Time Velocity Vectors (LVV hot spot) (First-site success rate). In cases of failure, the reason (safety concern, insufficient effect, or technical difficulty) will be recorded.
Key secondary outcomes
1.Acute procedural success rate.
2.Number of cryoablation applications (each application defined as one 240-second freeze cycle).
3.Total cryoablation time.
4.Total procedure time.
5.Fluoroscopy time and radiation dose (dose area product: DAP).
6.Change in PQ interval (pre- and post-procedure).
7.Incidence of complications within 30 days.
8.Recurrence rate within 3 months.
9.Presence, pattern, and reversibility of atrioventricular (AV) conduction disturbances leading to cryoablation termination at the LVV-identified target region (hot-spot).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cryoablation will be performed for typical atrioventricular nodal reentrant tachycardia guided by local activation time velocity vector analysis using the CARTO3 system.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who meet all of the following conditions will be enrolled:
1.Age 18 years or older.
2.Patients diagnosed with typical atrioventricular nodal reentrant tachycardia (slow-fast type) based on clinical findings and electrophysiological study.
3.Patients scheduled to undergo cryoablation with target localization guided by Local Activation Time Velocity Vector (LVV) analysis using the CARTO3 three-dimensional mapping system.
4.Patients who have received a full explanation of the study purpose and methods and have provided written informed consent.
5.Patients expected to be available for outpatient follow-up at 3 months after the procedure.
Key exclusion criteria
Participants meeting any of the following conditions will be excluded:
1.History of previous ablation for atrioventricular nodal reentrant tachycardia (AVNRT).
2.Patients whose primary arrhythmia mechanism is a manifest accessory pathway (for example, overt atrioventricular reentrant tachycardia).
3.Cases in which Kochs triangle cannot be adequately identified, making proper LVV analysis or target localization unfeasible.
4.Patients with severe atrioventricular conduction disturbance or marked bradycardia, in whom the investigator judges that study participation would compromise safety.
5.Pregnant women or those with a high likelihood of pregnancy.
6.Patients with serious comorbidities (for example, active infection or uncontrolled heart failure) that make study participation inappropriate in the judgment of the investigator.
7.Patients who are unable or unwilling to provide written informed consent, or who subsequently withdraw consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitake |
| Middle name | |
| Last name | Oshima |
Organization
Gifu Prefectural General Medical Center
Division name
Cardiology
Zip code
5008717
Address
4-6-1 Noisshiki, Gifu, Gifu
TEL
+81-582461111
yoshitakeoshima@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitake |
| Middle name | |
| Last name | Oshima |
Organization
Gifu Prefectural General Medical Center
Division name
Cardiology
Zip code
5008717
Address
4-6-1 Noisshiki, Gifu, Gifu
TEL
+81-582461111
Homepage URL
yoshitakeoshima@gmail.com
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Gifu Prefectural General Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu Prefectural General Medical Center
Address
4-6-1 Noisshiki, Gifu, Gifu
Tel
+81-582461111
yoshitakeoshima@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068216
