JPRN-jRCT2032200010
Recruiting
Phase 3
The Efficacy and Safety for Transcatheter Aortic Valve Replacement by Using Self-expandable Device in Dialysis Patients with Severe Aortic Stenosis - The Efficacy and Safety for TAVR by Using Self-expandable Device in Dialysis Patients with Severe Aortic Stenosis
Saito Shigeru0 sites10 target enrollmentApril 9, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- severe aortic stenosis
- Sponsor
- Saito Shigeru
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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