UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043747 |
|---|---|
| Receipt number | R000049942 |
| Scientific Title | Angioscopic evaluation for device neo-endothlialization and the residual shunt of patent foramen ovale closure device 12-months after implantation |
| Date of disclosure of the study information | 2021/03/26 |
| Last modified on | 2024/09/26 09:28:09 |
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Basic information
Public title
Angioscopic evaluation for device neo-endothlialization and the residual shunt of patent foramen ovale closure device 12-months after implantation
Acronym
Angioscopic evaluation of patent foramen ovale closure device neo-endothelialization
Scientific Title
Angioscopic evaluation for device neo-endothlialization and the residual shunt of patent foramen ovale closure device 12-months after implantation
Scientific Title:Acronym
Angioscopic evaluation of patent foramen ovale closure device neo-endothelialization
Region
| Japan |
Condition
Condition
patent foramen ovale
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the neo-endothelialization and the residual shunt of the patent foramen ovale closure device at 12-months after implantation
Basic objectives2
Others
Basic objectives -Others
To suggest the optimal antithrombotic therapy after trans-catheter closure for patent foramen ovale
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Device neo-endothelialization and the residual shunt at 12-months after implantation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent the trasns-catheter closure for the patent foramen ovale at St. Marianna University School of Medicine Hospital
Key exclusion criteria
Patients who do not agree with the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tanabe |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
TEL
+81-044-977-8111
y-tanabe@muj.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Tanabe |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
TEL
+81-44-977-8111
Homepage URL
y-tanabe@muj.biglobe.ne.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Abott Vascular Japan, Co.Ltd
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
IRB of St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
Tel
+81-44-977-8111
k-sienbu.mail@marianna-u.ac.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
| 2021 | Year | 03 | Month | 26 | 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
| 2021 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will assess the neo-endothelialization of the PFO closure device by angioscopy and residual shunt by the micro bubble test of trans esophageal ultrasound at 12-months after the implantation.
At September 26, 2024, 20 cases were enrolled. We intend to present the results to TCT2024 and prepare a paper.
Management information
Registered date
| 2021 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049942
