UMIN-CTR Clinical Trial

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