UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050294 |
|---|---|
| Receipt number | R000057264 |
| Scientific Title | Risk of coronary obstruction due to sinus sequestration by redo transcatheter aortic valve implantation in Japanese patients with SAPIEN 3 |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2023/02/09 20:43:58 |
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Basic information
Public title
Risk of coronary artery occlusion at second transcatheter aortic valve implantation
Acronym
Risk of coronary artery occlusion at second transcatheter aortic valve implantation
Scientific Title
Risk of coronary obstruction due to sinus sequestration by redo transcatheter aortic valve implantation in Japanese patients with SAPIEN 3
Scientific Title:Acronym
Risk of coronary obstruction due to sinus sequestration by redo transcatheter aortic valve implantation in Japanese patients with SAPIEN 3
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the proportion of Japanese patients who are expected to have difficulty undergoing a second transcatheter aortic valve implantation (TAVI) procedure, and to examine the possibility of reducing the risk of coronary artery occlusion by sinus of Valsalva (SOV) sequestration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study aims to clarify the proportion of the risk of sinus of Valsalva sequestration during TAV-in-TAV in Japanese patients.
Key secondary outcomes
To identify preoperative CT and echocardiographic parameters that predict the risk of sinus of Valsalva sequestration.
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent TAVI for severe aortic stenosis at Iwate Medical University Hospital and had SAPIEN3 (balloon-expanded transcatheter bioprosthetic valve) implanted. Patients who underwent aortography after implantation of the bioprosthetic valve.
Key exclusion criteria
Patients who underwent aortography but could not be adequately evaluated.
In addition, patients who were denied opt out.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Ninomiya |
Organization
Iwate Medical University Hospital
Division name
Department of Internal Medicine, Division of cardiology
Zip code
028-3695
Address
Idaidori 2-1 -1, Yahaba-cho, Siwa, Iwate prefecture, Japan 028-3695
TEL
019-613-7111
rnino0123@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Ninomiya |
Organization
Iwate Medical University Hospital
Division name
Department of Internal Medicine, Division of cardiology
Zip code
028-3695
Address
Idaidori 2-1 -1, Yahaba-cho, Siwa, Iwate prefecture, Japan
TEL
019-613-7111
Homepage URL
rnino0123@gmail.com
Sponsor or person
Institute
Iwate Medical University Hospital
Institute
Department
Personal name
Ryo Ninomiya
Funding Source
Organization
self-procurement
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
Iwate Medical University Hospital
Address
Department of Internal Medicine, Division of cardiology
Tel
019-613-7111
rnino0123@gmail.com
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
| 2023 | Year | 02 | Month | 14 | 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
308
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study items:
Patient background (age, gender, height, weight, BSA, STS score
Patient background (age, gender, height, weight, BSA, STS score, Clinical Frailty scale, hypertension, lipid abnormality, diabetes, atrial fibrillation)
Echocardiography (left ventricular ejection fraction, aortic valve orifice area, maximum aortic valve velocity, mean aortic valve pressure gradient, aortic valve annulus diameter, STJ diameter, left ventricular diameter, left ventricular wall thickness)
Preoperative CT (aortic valve annulus area, mean aortic valve annulus diameter, STJ height and diameter, left coronary artery height, Valsalva sinus diameter)
Size of the implanted valve
Fluoroscopic images (depth of implantation of biological valve, distance between biological valve and aortic valve annulus, and height relationship between STJ and biological valve commissure)
Methods of investigation:
(1) The above items were extracted using the preoperative medical data in the medical records.
2) Measurements will be made using fluoroscopic images of aortography.
(3) The distance between the left margin of the bioprosthetic valve and the aorta will be less than 2 mm, and the height of the commissure will be lower than the STJ.
Management information
Registered date
| 2023 | Year | 02 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057264
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