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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021445
Receipt No. R000024675
Scientific Title Stentless mitral valve replacement using autologous pericardium study
Date of disclosure of the study information 2016/04/01
Last modified on 2019/11/05

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Basic information
Public title Stentless mitral valve replacement using autologous pericardium study
Acronym Stentless mitral valve replacement using autologous pericardium study
Scientific Title Stentless mitral valve replacement using autologous pericardium study
Scientific Title:Acronym Stentless mitral valve replacement using autologous pericardium study
Region
Japan

Condition
Condition Mitral valve disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of stentless mitral valve replacement using autologous pericardium for mitral vavle disease that is indicated for surgical treatment but is not suitable for standard mitral valve repair.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Residual mitral regurgitation two weeks after surgery
Key secondary outcomes Adverse events in 6 months after surgery

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
Maneuver
Interventions/Control_1 Stentless mitral valve replacement using autologous pericardium
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Mitral valve disease that meets at least one of following conditions and is indicated for surgery
(1) Symptomatic acute severe MR
(2) Chronic severe MR and NYHA functional class II, III or IV symptoms in the absence of severe LV dysfunction (severe LV dysfunction is defined as ejection fraction less than 0.30). (3) Asymptomatic chronic severe MR with mild to moderate LV dysfunction, ejection fraction 0.30 to 0.60, and/or end-systolic dimension greater than or equal to 40 mm.
(4) Symptomatic (NYHA functional class III-IV) moderate or severe mitral stenosis when 1) percutaneous mitral balloon valvotomy is contraindicated because of left atrial thrombus despite anticoagulation or because concomitant moderate to severe MR is present, 2) the valve morphology is not favorable for percutaneous mitral balloon valvotomy, or 3) percutaneous mitral balloon valvotomy has failed.


2. Advamced mitral valve disease that standard mitral valve repair is difficult for and is unlikely to present durable results for.

3. Written informed consent is obtained.

Key exclusion criteria 1. Active malignancy
2. Dialysis
3. Participating in other trials
4. Myocardial infarction in the last 6 months
5. Stroke in the last 6 months
6. Previous percutaneous coronary stenting in a month before surgery
7. Concomitant procedures other than valvular operation
8. Severe left ventricular dysfunction (ejection fraction less than 0.30)
9. When excellent outcomes and prognosis are expected with standard prosthetic mitral valve replacement
10. When a principal investigator deems a patient inappropriate as a trial subject
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Shimizu
Organization Keio University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
TEL 03-5363-3804
Email hideyuki@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Shimizu
Organization Keio University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN
TEL 03-5363-3804
Homepage URL
Email hideyuki@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 04 Month 01 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 Terminated
Date of protocol fixation
2015 Year 12 Month 18 Day
Date of IRB
2016 Year 03 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2019 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 11 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024675

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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