UMIN-CTR Clinical Trial

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

Failing bioprosthetic Valve

Classification by specialty

Cardiology

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

grade I <= Improvement in NYHA classification

Key secondary outcomes

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

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

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

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

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

Institute

Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Edwards Lifescience

Organization

Division

Category of Funding Organization

Other

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

2015

Year

08

Month

01

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

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 related 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