UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter trial to assess transcatheter aortic valve replacement for chronic hemodialysis patients with aortic valve stenosis
Title of the study (Brief title)	Transcatheter aortic valve replacement for chronic hemodialysis patients
Region	Japan

Condition
Condition	Severe aortic valve stenosis Chronic kidney disease (hemodialysis patients)
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of transcatheter aortic valve replacement in hemodialysis patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of heart failure symptoms more than 1 grade in the NYHA classification at the postoperative 1st year
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who have a 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 5.Patient who is possible to visit on all follow-up days required after procedure
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 for any reason 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 18 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 mm making the safe insertion of sheath introducer impossible from the common iliac artery through the femoral artery
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuaki Mitsudo
Organization	Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital
Division name	Heart Disease Center
Address	1-1-1, Miwa, Kurashiki, Okayama
TEL	086-422-0210
Email	kenkyu@kchnet.or.jp

Public contact
Name of contact person	Harumi katoh
Organization	Kurashiki Central Hospital
Division name	Department of Cardiology
Address	1-1-1, Miwa, Kurashiki, Okayama
TEL	086-422-0210
Homepage URL
Email	kenkyu@kchnet.or.jp

Sponsor
Institute	Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital Heart Disease Center
Institute
Department

Funding Source
Organization	Public interest incorporated foundation Ohara HealthCare Foundation Kurashiki Central Hospital Department of Cardiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 24 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 28 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014504