UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047359 |
|---|---|
| Receipt number | R000054008 |
| Scientific Title | Efficacy and safety of primary percutaneous trans-axillary artery transcatheter aortic valve replacement for severe aortic stenosis |
| Date of disclosure of the study information | 2022/05/20 |
| Last modified on | 2024/04/02 09:23:18 |
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Basic information
Public title
Efficacy and safety of primary percutaneous trans-axillary artery transcatheter aortic valve replacement for severe aortic stenosis
Acronym
Primary trans-axillary artery access TAVR for AS
Scientific Title
Efficacy and safety of primary percutaneous trans-axillary artery transcatheter aortic valve replacement for severe aortic stenosis
Scientific Title:Acronym
Primary trans-axillary artery access TAVR for AS
Region
| Japan |
Condition
Condition
Severe aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For facilitating early mobilization and next-day discharge, the purposes of this study are to evaluate the efficacy and safety of percutaneous trans-axillary artery transcatheter aortic valve replacement as primary access for severe aortic stenosis with favorable femoral access for TAVR.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Achievement of next-day discharge after TAVR
Key secondary outcomes
1) Time of mobilization from TAVR procedure
2) Incidence of Delirium
3) Clinical/Subclinical stroke evaluated by MRI one day after procedure
Safety endpoint:
1) TAVR procedural success
2) Complication based on Valve academic research consortium-3 criteria
3) major vascular and/or bleeding complications based on Valve academic research consortium-3 criteria
4) 30-sy mortality
5) Clinical/Subclinical stroke evaluated by MRI one day after procedure
6) Other adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Percutaneous trans-axillary artery TAVR
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosis of severe aortic stenosis by transthoracic echocarrdiogram: (AVA<1.0cm2 or AVAi<0.6cm2/m2 )and (peak AV>4.0m/s or mean aortic gradient >40mmHg)
2) Age >74 at the time of TAVR
3) NYHA >1 symptom
4) LVEF >50%
5) Suitable femoral and axillary artery access for both transfemoral and transaxillary arteryTAVR by MDCT
6) Written informed consent
Key exclusion criteria
1) contraindication for bioprosthesis implantation
2) Contraindication for following medicine
aspirine, ticlopidine, heparine or contrast medium
3) active endocarditis or sepsis
4) Left ventricular thrombus
5) decompensated heart failure with NYHA4 symptom
6) Cardiogenic shock with hemodynamic mechanical support
7) Post coronary artery graft bypass using ipsilateral internal mammary artery
8) Post pacemaker implantation at ipsilateral axillary vein
9) coronary artery disease with Indication for coronary artery bypass graft surgery
10) Indication for surgical valvular treatment
11) Blood disease: WBC<1000mm3,Plt<50000cellc/mm3
12) Severe dementia
13) Life-expectancy<1year due to other than heart disease
14) pregnancy or breast-feed
15) access artery diameter<5mm by CT or echo
16) severe calcification or tortuosity of access
17) inhibitive anatomy for trans femoral access
18) Aorto-subclavian angle>90degree
19) Subclavian artery originated from distal aortic arch
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Saito |
Organization
Shonan Kamakura General Hospital
Division name
Cardiology
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura, Kanagawa
TEL
0467461717
transradial@kamakuraheart.org
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Moriyama |
Organization
Shonan Kamakura General Hospital
Division name
Cardiology
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura, Kanagawa
TEL
0467461717
Homepage URL
e2718nm@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
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
Tokushukai Group Institutional Review Board
Address
1-8-7 Koujimachi, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
| 2022 | Year | 05 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054008
