UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008659 |
|---|---|
| Receipt number | 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 14:16:03 |
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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
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
Sponsor or person
Institute
Senko Medical Instrument Mfg. Co. Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010176
