UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028278 |
|---|---|
| Receipt number | R000030512 |
| Scientific Title | Single Institution, Exploratory, Safety Evaluation Study of Mitral Valve-in-Valve Transcatheter Mitral Valve Implantation for Degenerated Bioprosthetic Heart Valve |
| Date of disclosure of the study information | 2017/07/19 |
| Last modified on | 2019/03/18 08:17:50 |
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Basic information
Public title
Single Institution, Exploratory, Safety Evaluation Study
of Mitral Valve-in-Valve Transcatheter Mitral Valve Implantation for Degenerated Bioprosthetic Heart Valve
Acronym
MITRAL VIV study
Scientific Title
Single Institution, Exploratory, Safety Evaluation Study
of Mitral Valve-in-Valve Transcatheter Mitral Valve Implantation for Degenerated Bioprosthetic Heart Valve
Scientific Title:Acronym
MITRAL VIV study
Region
| Japan |
Condition
Condition
failing bioprosthetic valve in the mitral position
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform a single-center, non-comparative, experiential, investigation to evaluate the safety of TAVI with devices approved for use in Japan for patients who have a failing bioprosthetic valve in the mitral position resulting in heart failure that is difficult for the cardiologist to manage and who cannot undergo elective open heart surgery due their high risk for open heart surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse events during the procedure(Safety) until postoperative 30th day
All cause mortality within 30 days post procedure
All stroke within 30 days post procedure
Life-threatening major bleeding within 30 days post procedure
Coronary artery lesions requiring revascularization within 30 days post procedure
Major vascular complications within 30 days post procedure
Structural valve failure requiring re-intervention within 30 days post procedure
Any other major adverse events or device related malfunctions within 30 days post procedure
Key secondary outcomes
Procedural Success(Efficacy)
Change from baseline in mitral valve function evaluated by TTE at 7 and 30 days post operatively
Change from baseline in NYHA functional class measured at 7 and 30 days post operatively
Change from baseline in performance of 6 minute walk test measured postoperative day 7
Change in left ventricular end-diastolic diameter (LVEDD) at 7 and 30 days post-op
Change from baseline in left ventricular ejection fraction at 7 and 30 days post op
Change from baseline in plasma BNP at 7 and 30 days post-op
Change from baseline in pulmonary artery wedge pressure (PAWP) immediately following procedure
Change from baseline in cardiac index (CI) immediately following the procedure
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
| Device,equipment |
Interventions/Control_1
Interventions: Transcatheter mitral valve implantation for high-risk patients with failed prosthetic mitral valve (valve-in-valve)
Period: From the clinical trial start date to March 2020 or to the date achieving target numbers (5 cases)
Device: SAPIEN XT (Edwards Life sciences, Irvine,CA)
Intervention times: one intervention per a patient, but there is a possibility of second valve-in-valve procedure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who are 20 years of age or more
2)Patients with failed prosthetic mitral valve
3)Patients with uncontrollable heart failure
4)High-risk patients for redo cardiac surgery
5)Patients or legal guardians who can declare for clinical trial documents
Key exclusion criteria
1)Patients with metal allergy
2)Patients with contrast media hypersensitivity
3)Patients with thrombus in left atrium or ventricle
4)Patients during shock state
5)Patients with failed prosthetic mitral valve induced by active infective endocarditis or during infection status
6)Patients with hemodialysis
7)Patients undergoing mechanical prosthetic mitral valve
8)Patients with possibility of pregnancy or during pregnancy or lactation
9)Patients joining other clinical trials or planning other clinical trials
10)Patients judged as inappropriate by the director or responsible doctors of this clinical trials
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Junjiro |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Surgery
Zip code
565-8565
Address
5-7-1, Fujishirodai, Suita, Osaka
TEL
06-6833-5012
jkobayas@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kizuku |
| Middle name | |
| Last name | Yamashita |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Cardiovascular Surgery
Zip code
565-8565
Address
5-7-1, Fujishirodai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
kizukuy@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
National Cerebral and Cardiovascular Center, Ethics Committee Secretariat
Address
5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
Tel
06-6833-5012
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
4
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030512
