UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028278
Receipt No. 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

* 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 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
Email 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
Email kizukuy@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030512

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.