UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026450
Receipt number R000026197
Scientific Title Single Institution, Exploratory, Safety Evaluation Study of Aortic Valve-in-Valve Transcatheter Aortic Valve Implantation for Degenerated Bioprosthetic Heart Valve
Date of disclosure of the study information 2017/03/07
Last modified on 2019/03/18 08:16:39

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Basic information

Public title

Single Institution, Exploratory, Safety Evaluation Study
of Aortic Valve-in-Valve Transcatheter Aortic Valve Implantation for Degenerated Bioprosthetic Heart Valve

Acronym

AORTIC VIV study

Scientific Title

Single Institution, Exploratory, Safety Evaluation Study
of Aortic Valve-in-Valve Transcatheter Aortic Valve Implantation for Degenerated Bioprosthetic Heart Valve

Scientific Title:Acronym

AORTIC VIV study

Region

Japan


Condition

Condition

failing bioprosthetic valve in the aortic position

Classification by specialty

Cardiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To perform a single-center, non-comparative, experiential, investigation to evaluate the safety of TAVI with devices approved for use in Japan for patients who have a failing bioprosthetic valve in the aortic position resulting in heart failure that is difficult for the cardiologist to manage and who cannot undergo elective open heart surgery due their high risk for open heart surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Major adverse events during the procedure(Safety) until postoperative 30th day
All cause mortality within 30 days post procedure
All stroke within 30 days post procedure
Life-threatening major bleeding within 30 days post procedure
Coronary artery lesions requiring revascularization within 30 days post procedure
Major vascular complications within 30 days post procedure
Structural valve failure requiring re-intervention within 30 days post procedure
Any other major adverse events or device related malfunctions within 30 days post procedure

Key secondary outcomes

Procedural Success(Efficacy)
Change from baseline in aortic valve function evaluated by TTE at 7 and 30 days post operatively
Change from baseline in NYHA functional class measured at 7 and 30 days post operatively
Change from baseline in performance of 6 minute walk test measured postoperative day 7
Change in left ventricular end-diastolic diameter (LVEDD) at 7 and 30 days post-op
Change from baseline in left ventricular ejection fraction at 7 and 30 days post op
Change from baseline in plasma BNP at 7 and 30 days post-op
Change from baseline in pulmonary artery wedge pressure (PAWP) immediately following procedure
Change from baseline in cardiac index (CI) immediately following the procedure


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

Medicine

Interventions/Control_1

Interventions: Transcatheter aortic valve implantation for high-risk patients with failed prosthetic aortic valve (valve-in-valve)
Period: From the clinical trial start date to March 2020 or to the date achieving target numbers (11 cases)
Device: SAPIEN XT (Edwards Life sciences, Irvine,CA) or CoreValve Evolut R(Medtronic, Inc., Minneapolis, MN, USA)
Intervention times: one intervention per a patient, but there is a possibility of second 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who are 20 years of age or more
2)Patients with failed prosthetic aortic valveincluding transcatheter aortic valve implantation
3)Patients with uncontrollable heart failure
4)High-risk patients for redo cardiac surgery
5)Patients or legal guardians who can declare for clinical trial documents

Key exclusion criteria

1)Patients with metal allergy
2)Patients with contrast media hypersensitivity
3)Patients with thrombus in left atrium or ventricle
4)Patients during shock state
5)Patients with failed prosthetic aortic valve induced by active infective endocarditis or during infection status
6)Patients with hemodialysis
7)Patients undergoing mechanical prosthetic aortic valve
8)Patients with possibility of pregnancy or during pregnancy or lactation
9)Patients joining other clinical trials or planning other clinical trials
10)Patients judged as inappropriate by the director or responsible doctors of this clinical trials

Target sample size

11


Research contact person

Name of lead principal investigator

1st name Junjiro
Middle name
Last name Kobayashi

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Surgery

Zip code

565-8565

Address

5-7-1, Fujishirodai, Suita, Osaka

TEL

06-6833-5012

Email

jkobayas@ncvc.go.jp


Public contact

Name of contact person

1st name Kizuku
Middle name
Last name Yamashita

Organization

National Cerebral and Cardiovascular Center

Division name

Department of Cardiovascular Surgery

Zip code

565-8565

Address

5-7-1, Fujishirodai, Suita, Osaka, Japan

TEL

06-6833-5012

Homepage URL


Email

kizukuy@ncvc.go.jp


Sponsor or person

Institute

National Cerebral and Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cerebral and Cardiovascular Center, Ethics Committee Secretariat

Address

5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan

Tel

06-6833-5012

Email

rec-office-ac@ncvc.go.jp


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

2017 Year 03 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-17-0851/_html/-char/ja

Number of participants that the trial has enrolled

11

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

2016 Year 08 Month 23 Day

Date of IRB

2016 Year 08 Month 23 Day

Anticipated trial start date

2016 Year 10 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 03 Month 07 Day

Last modified on

2019 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026197


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name