CTRI/2024/05/067405
Not yet recruiting
Phase 1
Safety and performance of a novel transcatheter treatment for symptomatic aortic stenosis by aortic pressure recovery - Nil
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
- Sponsor
- Translumina Therapeutics LLP
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Assessment and approval by site investigator and sponsor assignee, that patient is eligible candidate for this treatment and study.
- •2\. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by
- •the applicable Medical Ethics Committee (EC).
- •3\. Greater than 18 years of age
- •4\. Aortic sinotubular junction (STJ) diameter meets the range of 25 to 32 mm, as measured by CT (performed within the past 180 days).
- •5\. Aortic brachiocephalic diameter meets the range of 27 to 35 mm, as measured by CT (performed within the past 180 days).
- •6\. Patient has severe degenerative aortic stenosis with echocardiography derived mean gradient \>40mmHg, and/or peak velocity greater than
- •4\.0 m/s, and/or an initial valve area of \<1\.0 cm2
- •7\.Patient has symptomatic aortic stenosis as demonstrated by NYHA of II or greater.
- •8\. Patient is within the acceptable surgical risk aortic valve replacement, as assessed by the site investigator and sponsor assignee.
Exclusion Criteria
- •1\. Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 12 months.
- •2\. Patient has carotid artery disease requiring intervention.
- •3\. Patient has evidence of a myocardial infarction (MI) within the past 3 months.
- •4\. Patient has hypertrophic cardiomyopathy, based on physician discretion.
- •5\. Patient has a native aortic valve with an abnormal, or eccentric jet, as assessed by echo.
- •6\. Patient has mitral or tricuspid valvular regurgitation of grade III or moderate mitral stenosis, as assessed by echo.
- •7\. Patient has aortic regurgitation more than mild.
- •8\. Patient has rheumatic heart disease
- •9\. Patient had prior CABG operation with ascending aorta grafts.
- •10\. Patient has a pre\-existing prosthetic valve or prosthetic ring in any position.
Outcomes
Primary Outcomes
Not specified
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