UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000030512