UMIN-CTR Clinical Trial

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

Mitral regurgitation

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Sakakibara Heart Institute

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

12

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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