UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018398
Receipt number R000021110
Scientific Title Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve
Date of disclosure of the study information 2015/08/01
Last modified on 2018/12/27 11:17:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve

Acronym

Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve

Scientific Title

Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve

Scientific Title:Acronym

Efficacy and Safety of Transcatheter Valve-in-Valve Implantation for Failing Bioprosthetic Valve

Region

Japan


Condition

Condition

Failing bioprosthetic Valve

Classification by specialty

Cardiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the efficacy and safety of transcatheter valve-in-valve implantation for failing bioprosthetic valve in Japan.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

grade I <= Improvement in NYHA classification

Key secondary outcomes



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 Maneuver

Interventions/Control_1

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. At least 1 surgeon and 1 cardiologist that the patient was not a suitable candidate for surgery because of comorbidities
Aortic bioprosthesis
2-A. AVA<=1.0 (or AVAI <=0.5)
or
2-B. severe regurgitation
or
2-C. AVA<=1.5 and >=moderate valve regurgitation

Mitral bioprosthesis
2-D. valve area <=1.0
or
2-E. severe regurgitation
or
2-F. valve area <=1.5 and >=moderate valve regurgitation
3. NYHA class 3 (if not, then agreement was required from at least 1 surgeon and 1 cardiologist)
4. all patients provided written informed consent

Key exclusion criteria

1. history of coronary infarction within previous 1 month
2. PCI or PTA within previous 1 month
3-1. WBC<1000
3-2. Plt<50000
3-3. history of coagulation disorder
3-4. hyper coagulability state
4. untreated coronary artery disease requiring revascularization
5. cardiac shock or state requiring mechanical support
6. emergent operation
7. EF <20%
8. CVA or TIA within previous 1 month
9. active gastrointestinal bleeding
10. 1 Aspirin, 2 ticlopidine hydrochloride, 3 heparin, 4 contrast agents, 5 Nitinol was contraindication.
11. active endocarditis
12. refusal of blood transfusion
13. life expectancy less than 12 months due to associated non-cardiac comorbid condition
14. severe dementia
15. participation of other clinical trial
16. carotid or vertebral artery stenosis with symptoms
17. Heart team is not agree regarding medical, social, or psychological state
18. at least 1 cardiovascular surgeon and 1 cardiologist are not agree regarding anatomical findings.
19. HCM
20. presence of vegetation
21. HOCM
22. potential of coronary obstruction

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshi Sawa

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

2-2 Yamadaoka Suita Osaka

TEL

06-6879-3154

Email

sawasec@surg1.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Maeda

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code


Address

2-2 Yamadaoka Suita Osaka

TEL

06-6879-3154

Homepage URL


Email

k-maeda@surg1.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Edwards Lifescience

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

2015 Year 08 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

Completed

Date of protocol fixation

2014 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 23 Day

Last modified on

2018 Year 12 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021110


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name