UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective comparison of porcine pericardial prostheses in patients with severe aortic stenosis and reduced cardiac function
Title of the study (Brief title)	J-league trial
Region	Japan

Condition
Condition	aortic stenosis
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of hemodynamics between inner- and outer-mounted pericardial valves
Basic objectives2	Others
Basic objectives -Others	Survival and freedom from valve related complications
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Peak pressure gradient at 1 years after implantation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Trifecta valve 50 cases
Interventions/Control_2	Magna valve 50 cases
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	60 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1,Low ejection fraction (<50%) on preoperative echocardiography 2. Surgical aortic valve replacement without prior pericardiotomy and catheter aortic valve intervention 3. Including concomitant coronary artery bypass, ascending aortic replacement, and tricuspid annuloplasty 4. Severe aortic stenosis (preoperative peak pressure gradient >64mmHg, mean pressure gradient >40mmHg, or aortic valve area <1.0 cm2) 5. Planned implanted valve size is 19-21mm (Annulus diameter <21mm on preoperative echocardiography)
Key exclusion criteria	1. concomitant mitral valve surgery 2. Aortic root replacement 3. age < 60 years 4. Patients with no preoperative echocardiography data 5. emergency surgery 6. Chronic hemodialysis
Target sample size	100

Research contact person
Name of lead principal investigator	Yutaka Okita
Organization	Kobe University, graduate school of medicine, Department of Surgery
Division name	Division of Cardiovascular Surgery
Address	7-5-1, Kusunokicho, Chuoku, Kobe
TEL	0783825942
Email	yutakaokita@gmail.com

Public contact
Name of contact person	Hiroshi Tanaka
Organization	Kobe University, graduate school of medicine, Department of Surgery
Division name	Division of Cardiovascular Surgery
Address	7-5-1, Kusunokicho, Chuoku, Kobe
TEL	0783825942
Homepage URL
Email	hirtanak@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	St. Jude Medical
Organization
Division
Category of Funding Organization	Profit organization
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	2018 Year 03 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 03 Month 09 Day
Last modified on	2018 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034688