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 2022/07/20 11:34:18

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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

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 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

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

Enrolling by invitation

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 07 Month 20 Day



Link to view the page

Value
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