UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041629 |
|---|---|
| Receipt number | R000047521 |
| Scientific Title | Perceval Bioprosthetic Valve Post Marketing Surveillance |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2020/09/04 07:42:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Perceval Bioprosthetic Valve Post Marketing Surveillance
Acronym
Perceval Bioprosthetic Valve Post Marketing Surveillance
Scientific Title
Perceval Bioprosthetic Valve Post Marketing Surveillance
Scientific Title:Acronym
Perceval Bioprosthetic Valve Post Marketing Surveillance
Region
| Japan |
Condition
Condition
Replacement of diseased aortic valve or malfunctioning artificial aortic valve by open-heart operations
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this post market surveillance (PMS) is to confirm the safety and efficacy in all subjects implanted with a Perceval Bioprosthetic Valve, which is used for replacement of diseased aortic valve or malfunctioning artificial aortic valve by open-heart operations. The study will be conducted in accordance with conditional approval by Japan regulatory authority (Ministry of Health, Labor and Welfare) for the study device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Safety
Presence and occurrence rate of device deficiencies and adverse events on intra-surgery and during postoperative follow-up period
Key secondary outcomes
2) Effectiveness
Postoperative improvement of Patient Symptoms and hemodynamics
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
Patients who are implanted with a Perceval Bioprosthetic Valve during the enrollment period
Key exclusion criteria
NA
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Eguchi |
Organization
LivaNova Japan K.K.
Division name
Clinical and Scientific Affairs
Zip code
100-6110
Address
Sanno Park Tower 10F 2-11-1. Nagatacho, Chiyoda-ku Tokyo 100-6110 Japan
TEL
+81-3-3595-7630
Susumu.eguchi@livanova.com
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Eguchi |
Organization
LivaNova Japan K.K.
Division name
Clinical and Scientific Affairs
Zip code
100-6110
Address
Sanno Park Tower 10F 2-11-1. Nagatacho, Chiyoda-ku Tokyo 100-6110 Japan
TEL
+81-3-3595-7630
Homepage URL
Susumu.eguchi@livanova.com
Sponsor or person
Institute
LivaNova Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
None
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
NA
Address
NA
Tel
None
None
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
| 2020 | Year | 09 | Month | 04 | 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
204
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 09 | Month | 01 | Day |
Last modified on
| 2020 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047521
