UMIN-CTR Clinical Trial

Public title

Transcatheter aortic valve replacement for patients with aortic valve stenosis

Acronym

Transcatheter aortic valve replacement

Scientific Title

Transcatheter aortic valve replacement for patients with aortic valve stenosis

Scientific Title:Acronym

Transcatheter aortic valve replacement

Region

Japan

Condition

Severe aortic valve stenosis

Classification by specialty

Cardiology

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the safety and efficacy of transcatheter aortic valve replacement

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Improvement of heart failure symptoms more than 1 grade in the NYHA classification at the 6th postoperative month

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Edwards SAPIEN Transcatheter Heart Valve

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who have high risk for operative mortality or are 'non- operable' as determined by cardiologist and cardiovascular surgeon
2.Severe aortic valve stenosis with the mean pressure gradient more than 40 mmHg, velocity more than 4.0 m/sec, or aortic valve area less than 0.8 cm2 by ultrasound cardiography
3.Heart failure symptoms with the NYHA classification greater than class II
4.Patient or substitute decision-maker signed the written informed consent, which had been approved by the institutional review board or its equivalence

Key exclusion criteria

1. Acute myocardial infarction within 1 month
2. Unicuspid, bicuspid aortic valve, or aortic valve stenosis without calcification
3. Severe aortic valve regurgitation
4. Cardiac intervention within 2 weeks
5. Prior valve surgery with artifical valve ring or severe mitral valve regurgitation with level 3 or 4
6. Leukopenia, acute anemia, thrombocytopenic purpura, or past history of coagulation disorder
7. Coronary artery disease with significant stenosis requiring intervention.
8. Unstable circulation requiring mechanical support
9. Emergency procedure
10. Obstructive or nonobstructive cardiomyopathy
11. Severe LV dysfunction (LVEF<20%)
12. Cardiac tumor, thrombus, vegetation in UCG
13. Active gastrointestinal ulcer or history of upper gastrointestinal bleeding within 3 months
14. Allergy to aspirin, heparin, ticropigin, or contrast medium
15. Aortic valve annulus smaller than 16 mm or larger than 25 mm
16. CVA or TIA within 1 month
17. Life expectancy less than 12 months due to non-cardiac disease
18. Involvement in another clinical trial
19. Active bacterial endocarditis or other active infections
20. Massive calcified cusp of aortic valve close to the coronary ostium
21. Allergy to cobalt-chromium alloy
22. Abdominal or thoracic aortic aneurysm or atheroma (diameters more than 5 cm ), and serious denaturation or anatomical features of thoracoabdominal aorta
23. Severe calcification, extreme tortuosity and vessel diameter less than 6.5 mm making the safe insertion of sheath introducer impossible from the common iliac artery through the femoral artery

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Kazuaki Mitsudo

Organization

Kurashiki Central Hospital

Division name

Heart Disease Center

Zip code

Address

1-1-1, Miya, Kurashiki, Okayama

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kurashiki Central Hospital

Division name

Department of Cardiology, Department of Cardiovascular Surgery

Zip code

Address

TEL

Homepage URL

Email

Institute

Kurashiki Central Hospital
Department of Cardiology
Department of Cardiovascular Surgery

Institute

Department

Personal name

Organization

Kurashiki Central Hospital
Department of Cardiology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

倉敷中央病院　心臓病センタ-　循環器内科　心臓血管外科

Date of disclosure of the study information

2012

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

06

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

30

Day

Last modified on

2015

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010835