UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063013 |
|---|---|
| Receipt number | R000072139 |
| Scientific Title | Registry development specific to transcatheter pulmonary valve implantation including right ventricular outflow tract morphology and device implantation type |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/21 17:04:00 |
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Basic information
Public title
Registry study on right ventricular outflow tract morphology and device type in transcatheter pulmonary valve implantation (TPVI)
Acronym
Pediatrics and adult cardiology (PEARL) -TPVI registry
Scientific Title
Registry development specific to transcatheter pulmonary valve implantation including right ventricular outflow tract morphology and device implantation type
Scientific Title:Acronym
Pediatrics and adult cardiology (PEARL) -TPVI registry
Region
| Japan |
Condition
Condition
Congenital heart disease with right ventricular outflow tract dysfunction (pulmonary valve stenosis/insufficiency) requiring transcatheter pulmonary valve implantation
Classification by specialty
| Cardiology | Pediatrics | Cardiovascular surgery |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects on cardiac function and the factors affecting long-term outcomes and fatal arrhythmias in patients who undergo transcatheter pulmonary valve implantation (TPVI). Specifically, sub-research questions include, but are not limited to: 1) identification of anatomical and clinical factors affecting long-term results; 2) investigation of predictors for thrombus formation and valvular dysfunction in bioprosthetic valves; 3) evaluation of changes in biventricular function and hemodynamics including diastolic function; 4) investigation of effects on atrioventricular valve function; 5) identification of factors related to occurrence of arrhythmia events; 6) establishment of optimal antithrombotic therapy; 7) identification of optimal treatment timing and appropriate indications.
Basic objectives2
Others
Basic objectives -Others
Observational - natural history / prognostic factor exploration
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Freedom from re-intervention due to valve dysfunction (stenosis or insufficiency). Valve dysfunction is defined as the occurrence of any of the following after the initial TPVI procedure: RVOT re-operation rate attributable to the Product; catheter-based reintervention of the transcatheter pulmonary valve (TPV); or hemodynamic dysfunction of the TPV (defined as pulmonary valve regurgitation of moderate or greater severity and/or a mean RVOT pressure gradient exceeding 40 mmHg).
Key secondary outcomes
1) Overall survival
2) Incidence of arrhythmia events (ventricular tachycardia, atrial fibrillation, etc.) and implementation rate of therapeutic intervention
3) Changes over time in biventricular function including diastolic function and pulmonary blood pressure
4) Thrombus formation rate and related factors
5) Change in atrioventricular valve function
6) Relationship between anatomical characteristics/type of device implantation and prognosis
7) Relationship between antithrombotic therapy and valve function/thrombus formation
8) Consideration of appropriateness of indication for intervention
9) Adverse Events: hemodynamic dysfunction of the TPV, thrombosis of the TPV, endocarditis of the TPV, structural damage to the TPV frame, any reintervention on the TPV (including explantation), coronary artery compression, new arrhythmias requiring therapeutic intervention
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with congenital heart disease who underwent TPVI (using the Harmony Transcatheter Pulmonary Valve System) at study sites between March 2023 and March 2030.
2) Patients from whom written consent has been obtained from the patient him/herself or his/her legally acceptable representative (for patients from whom consent cannot be obtained, such as those who do not visit the hospital on an outpatient basis or those who died, existing information will be obtained by opt-out).
Key exclusion criteria
Patients who are judged by the principal investigator to be inappropriate as study subjects. For patients who are subject to opt-out, those who refused to participate will be excluded.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Fujimoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pediatric Cardiology
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
TEL
81-6-6170-1070
kfkazuto@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Fujimoto |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Pediatric Cardiology
Zip code
564-8565
Address
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
TEL
81-6-6170-1070
Homepage URL
https://www.ncvc.go.jp/research/clinical-research/
kfkazuto@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Kazuto Fujimoto
Funding Source
Organization
Medtronic plc (Research Grant through External Research Program)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
National Cardiovascular Center, Department of Pediatric Cardiology (Donations)
IRB Contact (For public release)
Organization
Research Ethics Review Committee, National Cardiovascular Center
Address
6-1 Kishibe-Shimmachi, Suita, Osaka, 564-8565, Japan
Tel
81-6-6170-1070
rec-office-ac@ncvc.go.jp
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
国立循環器病研究センター（大阪府)、東京女子医科大学（東京都)、愛媛大学医学部附属病院（愛媛県）、昭和医科大学（東京都）、筑波大学附属病院（茨城県）、京都府立医科大学（京都府)、静岡県立こども病院 (静岡県)、岡山大学 (岡山県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Planned publications: JACC: Cardiovascular Interventions and Circulation Journal. Planned conference presentations: CSI and ACC.
Management information
Registered date
| 2026 | Year | 09 | Month | 21 | Day |
Last modified on
| 2026 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072139
