UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051216 |
|---|---|
| Receipt number | R000058407 |
| Scientific Title | Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2024/12/09 17:52:48 |
* 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
Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance
Acronym
Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance
Scientific Title
Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance
Scientific Title:Acronym
Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance
Region
| Japan |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of the product when used in chronic dialysis patients under actual conditions of post-marketing use in Japan.
Based on the results of this surveillance, we will promote the proper use of the product and disseminate safety information.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)All-cause death or disabling stroke at 1 year
2)Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) event-free rates and the occurrence of individual MACCE components at 30 days, 6 months, 1year and annually up to 5 years
-all-cause death
-myocardial infarction (MI)
-all stroke
-reintervention
3)Major Adverse Events (MAE) at 30 days, 6 months, 1 year and annually up to 5 years
-MACCE
-Acute kidney Injury
-Cardiac tamponade
-Prosthetic valve dysfunction
-Cardiogenic shock
-Valve endocarditis
-Life-threatening, disabling or major bleeding
-Serious vascular complication
-Cardiac perforation
-Device migration/Valve embolism
4)Conduction disturbance requiring permanent pacemaker implantation at 30 days, 6 months, 1 year and annually up to 5 years
5)Change in NYHA class from baseline at 30 days, 6 months, 1year and annually up to 5 years
6)Echocardiographic assessment of valve performance at 30 days, 6 months, 12 months and annually up to 5 years
-transvalvular mean gradient
-effective orifice area (EOA)
-degree of aortic valve regurgitation
7)Cardiovascular deaths and valve-related deaths at 30 days, 6 months, 1 year and annually up to 5 years
Cardiovascular death:
-Any death due to proximate cardiac cause (e.g. MI, cardiac tamponade, worsening heart failure)
-All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure
-Death caused by non-coronary vascular conditions such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease
Valve-related death:
-Any death caused by prosthetic valve dysfunction, valve thrombosis, embolism, bleeding event, or implanted valve endocarditis
-Death related to reintervention on the operated valve.
8)Strokes (of any severity) and TIAs at 30 days, 6 months, 1 year and annually up to 5 years
9)Device success
10)Procedural success
defined as device success and absence of in-hospital MACCE
Key secondary outcomes
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
In the surveillance, chronic dialysis patients* who are used the product at the surveillance sites (PRO+model: 23 mm, 26 mm, 29 mm, 34 mm, FX model: 23 mm, 26 mm, 29 mm, 34 mm) are subjects to be surveyed.
This product is a self-expanding percutaneous aortic valve system (porcine pericardium tissue valve) which used for the percutaneous heart valve replacement and indicated for the following patients.
-Patients with severe symptomatic native aortic stenosis caused by the calcification of native aortic valve leaflets and whom are determined that the therapy using this product is the most suitable treatment. However, in the case of chronic dialysis patients, it is limited to those patients who are unable to undergo surgery, and whom are determined that the therapy using this product is the most suitable treatment.
-Patients with valvular disease caused by failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve, and who are unable to undergo surgery, and whom are determined that the therapy using this product is the most suitable treatment. 34 mm size TAV is only for the native aortic.
Key exclusion criteria
N/A
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Tajima |
Organization
Medtronic Japan
Division name
Clinical Research and Medical Science
Zip code
108-0075
Address
Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
TEL
03-6776-0007
ai.tajima2@medtronic.com
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Tajima |
Organization
Medtronic Japan
Division name
Clinical Research and Medical Science
Zip code
108-0075
Address
Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
TEL
03-6776-0007
Homepage URL
ai.tajima2@medtronic.com
Sponsor or person
Institute
Medtronic Japan
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
N/A
Address
N/A
Tel
N/A
N/A
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT2052230032
Org. issuing International ID_1
jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 31 | 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
| 2023 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058407
