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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000008659
Receipt No. R000010176
Scientific Title Clinical Research of the ON-X Prosthetic Heart Valve
Date of disclosure of the study information 2012/08/10
Last modified on 2012/08/21

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Basic information
Public title Clinical Research of the ON-X Prosthetic Heart Valve
Acronym Clinical Research of the ON-X Prosthetic Heart Valve
Scientific Title Clinical Research of the ON-X Prosthetic Heart Valve
Scientific Title:Acronym Clinical Research of the ON-X Prosthetic Heart Valve
Region
Japan

Condition
Condition Patients with valvular heart disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the clinical safety and efficacy of the ON-X mechanical heart valve. This study is also to explore the safety and efficacy of the ON-X aortic valve on low dose anticoagulation.



Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoints are the rate of occurrence of valve thrombosis, thromboembolism, bleeding, acitve endocarditis during the study period. Hemolytic potential demonstrated by serum lactate dehydrogenase at 1-year and postoperative hemodynamics (EOA and pressure gradient) will be also assessed.




Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Standard anticoagulation therapy in patients with aortic mechanical heart valve

Interventions/Control_2 Low dose anticoagulation therapy (PT-INR 1.3-1.8) in patients with aortic mechanical heart valve

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
21 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who are sifficiently ill to warrant replacement of their diseased natural or prosthetic valve, based on standard cardiovascular diagnostic workups. 2. Patients who are in sufficient satisfactory condition to be an average operative risk. 3. Patients who require an isolated aortic, or an isolated mitral valve replacement. 4. Patients who have agreed to return for the required follow-up visits.

Key exclusion criteria 1. Patients who are pregnant, or planning to become pregnant. 2. Patients who have a major noncardiac terminal disease. 3. Patients with active endocarditis. 4. Patients who require tricuspid valve replacement. 5. Patients who underwent coronary artery bypass surgery and require aspirin therapy. 6. Patients who require antiplatelet therapy. 7. Patients with a previous prosthetic valve, where it is not being replaced by a study valve, or patients requiring multiple valve replacement.


Target sample size 1400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Kawazoe
Organization St. Luke's International Hospital
Division name Cardiovascular Center
Zip code
Address 9-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Senko Medical Instrument Mfg. Co. Ltd.
Division name Sales & Marketing Division
Zip code
Address 3-23-13 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-4009
Homepage URL
Email

Sponsor
Institute Senko Medical Instrument Mfg. Co. Ltd.
Institute
Department

Funding Source
Organization Senko Medical Instrument Mfg. Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 08 Month 10 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 Enrolling by invitation
Date of protocol fixation
2005 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 05 Day
Last follow-up date
2017 Year 12 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
2012 Year 08 Month 09 Day
Last modified on
2012 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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