The Efficacy and Safety for TAVR by Using Self-expandable Device in Dialysis Patients with Severe Aortic Stenosis

JRCT ID: jRCT2032200010

Registered date:09/04/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: severe aortic stenosis
• Date of first enrollment: 09/04/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Transcatheter Aortic Valve Replacement by Using Self-expandable Device

Outcome(s)

• Primary Outcome: The primary endpoint is all-cause death or major stroke at 12 months.

Secondary Outcome

Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) event rate. MACCE is defined as a composite of:
All-cause death
Myocardial infarction (MI)
All stroke, and
Reintervention
2) The occurrence of individual MACCE components.
3) Conduction disturbance requiring permanent pacemaker implantation
4) Cardiovascular deaths and valve-related deaths
5) Strokes (of any severity) and TIAs
If the patients have any symptoms that are suspected for stroke, the patients are consulted and evaluated by neurologist. Head Magnetic Resonance Imaging (MRI) is planned to perform before and after procedure regardless of any symptoms.
6) Hospital stay
1 Hospital stay at 12 months
2 Length of index procedure hospital stay
3 Hospitalization related with aortic disease
4 Re-hospitalization after TAVR procedure

2 Change in NYHA class
3 Change in distance walked during 6-minute walk test (6MWT)
4 Quality of Life (QoL) change using the following measures:
Kansas City Cardiomyopathy Questionnaire (KCCQ)
SF-36
5 Echocardiographic assessment of valve performance (VARC 2)
transvalvular mean gradient
effective orifice area
degree of aortic valve regurgitation (transvalvular and paravalvular)
left ventricular mass index
left ventricular global longitudinal strain pattern
6 Prosthetic Valve thrombosis and deformation of flame of prosthetic valve by the multislice CT at discharge, 1 year and annually up to 5 years
7 Device success defined as follows:
Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,
correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),
Intended performance of the prosthetic valve (mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR).
8 success rate of procedure defined as
device success without MACCE

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1)The patients with severe aortic stenosis (AS)
2)The patients have AVA < 1.0 cm2 or EOAi < 0.5 cm2/m2 and Mean PG > 40 mmHg or Peak aortic-jet velocity > 4.0 m/s in transthoratic echocardiograply at rest or dobtamin stress echocardiography.
3)The patients have symptomatic severe AS with >= NYHA class 2
4)The patients have high risk for surgical aortic valve replacement in heart team discussion
5)The patients with dialysis. The patients have performed maintained dialysis >= 1 month as stable.
6)The patients have performed maintained dialysis including either peritoneal dialysis or hemodialysis.
7)The patients >= 20 years old and >= 90 years old.
8)The patients agree this study and write informed consents after they understand this study protocol.

Exclude criteria

1) The patients with low ejection fraction (less than 20%).
2) The patients with myocardial infarction within 30days.
3) The patients with fresh bleeding.
4) The patients with cerebral infarction within 6 months.
5) The patients with hemoglobin < 8.0 g/dl.
6) The patients with WBC <3000 or PLT < 100000.
7) The patients with positive HBV or HCV or HIV.
8) The patients with participate other clinical trial.
9) The patients with pregnant women (including possible) or lactating women
10) The patients that research director or contributory members judged inappropriate patients in this study.
11) The patients with need for emergency operation even if any reason.
12) The patients who have a life expectancy of less than 12 months due to comorbidities without cardiac disease.

Related Information

• Primary Sponsor: Saito Shigeru