Transfemoral Replacement of Aortic Valve with HLT MeriDIAN Valve CE Mark Trial

• Conditions: severe aortic stenosis; 10046973

• Registration Number: NL-OMON48296
• Lead Sponsor: HLT, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Echocardiographic or hemodynamic based evidence of severe aortic stenosis
with one of the following:
a) Aortic valve area <= 1.0 cm2 or 0.6 cm2/m2
b) Mean aortic valve gradient >= 40 mmHg
c) Peak aortic valve velocity >= 4 m/sec
2. Symptom*s due to severe aortic stenosis resulting in one of the following:
a) NYHA Functional Classification of II or greater
b) Presence of angina
c) Presence of syncope, 3. Documented aortic valve annular size of >= 24 and <=
26 mm (associated perimeter range is 76-81mm or associated area range of
453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging. ,
4. Patient is considered intermediate or high risk to undergo surgical aortic
valve replacement with one of the following:
a) Direct surgical risk STS-PROM score of >= 3% till 8%
b) great surgical risk STS-PROM score >=8%
C) Documented heart team agreement of risk for surgical aortic valve
replacement (SAVR) due to other factors not captured by risk-scores (i.e.
frailty or comorbidities)
5. Geographically available, willing to comply with follow up and able to
provide written informed consent

Exclusion Criteria

1. 1. Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic
valve; or valve eccentricity (calcific or otherwise) which could compromise
procedural success , 3. Patients with low flow/low gradient aortic stenosis
4. Patients with significant annular or LVOT calcification that could
compromise procedural success
5. Pre-existing prosthetic heart valve in any position, or prosthetic ring
7. Moderate to severe mitral stenosis
8. Myocardial infarction within the past 30 days*
10. Left Ventricular Ejection Fraction (LVEF) < 30%
22 Need for emergent surgery or intervention other than the investigational
procedure
23 Any therapeutic invasive cardiac procedure performed or planned to perform
within 30 days of the index procedure, except for PCI which is within 7 days of
the index procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified