UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047359
Receipt No. 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 2022/05/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email e2718nm@gmail.com

Sponsor
Institute Shonan Kamakura General Hospital
Institute
Department

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
Email 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 Preinitiation
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
2022 Year 05 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054008

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.