UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012659
Receipt number R000014745
Scientific Title Stentless mitral valve replacement using autologous pericardium study
Date of disclosure of the study information 2013/12/24
Last modified on 2020/06/29 12:26:45

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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 regurgitation

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

Residual and recurrent mitral regurgitation 12 months after surgery, adverse events in 12 months after surgery, and adverse events in 60 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

16 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

We include patients who meet all of the followings.
1. Diagnosis of mitral regurgitation
2. 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.

3. Advamced mitral valve disease that standard mitral valve repair is difficult for and is unlikely to present durable results for. (must meet at least one of the followings)
(1) Redo mitral valve surgery 6 months or longer after the previous mitral valve surgery.
(2) Infective endocarditis extending over the anterior and posterior leaflets

4. Written informed consent is obtained from the patient or his/her parental authority.

5. Patient age must be 16 or older and under 70 at the time of consent.



Key exclusion criteria

1. Active malignancy except for in situ cancer
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 tricuspid valve repair, maze operation and pulmonary vein isolation.
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

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitoshi Kasegawa

Organization

Sakakibara Heart Institute

Division name

Department of Cardiovascular Surgery

Zip code


Address

3-16-1 Asahicho, Fuchu-shi, Tokyo 183-0003, JAPAN

TEL

042-314-3111

Email

zbn25716@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Natsumi Takahashi

Organization

Sakakibara Heart Institute

Division name

Division of Clinical Research

Zip code


Address

Fuchu-shi, Tokyo 183-0003, JAPAN

TEL

042-314-3111

Homepage URL


Email

tikenjim@shi.heart.or.jp


Sponsor or person

Institute

Sakakibara Heart Institute

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2013 Year 12 Month 24 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

2014 Year 12 Month 08 Day

Date of IRB

2013 Year 12 Month 16 Day

Anticipated trial start date

2015 Year 04 Month 01 Day

Last follow-up date

2020 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 24 Day

Last modified on

2020 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014745


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name