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

Phase 3

Recruiting

• Conditions: severe aortic stenosis; aortic stenosis

• Registration Number: JPRN-jRCT2032200010
• Lead Sponsor: Saito Shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is all-cause death or major stroke at 12 months.