HLT Meridian Valve CE Mark Trial
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart
 disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate
 or High Risk for aortic valve replacement surgery.
Prospective, non-randomized, single arm, multi-center CE Mark trial.
Inclusion Criteria:

 -  Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of
 the following:

 1. Aortic valve area ≤ 1.0 cm^2 or 0.6 cm^2/m^2

 2. Mean aortic valve gradient ≥ 40 mmHg

 3. Peak aortic valve velocity ≥ 4 m/sec

 -  Symptoms due to severe aortic stenosis resulting in one of the following:

 1. NYHA Functional Classification of II or greater

 2. Presence of angina

 3. Presence of syncope

 -  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.

 -  Patient is considered intermediate or high risk to undergo surgical aortic valve
 replacement with one of the following:

 1. Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%

 2. High Surgical Risk: STS-PROM score of ≥ 8%

 3. 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)

 -  Geographically available, willing to comply with follow up and able to provide written
 informed consent

 Exclusion Criteria:

 -  Patients with a coronary height of <10mm, or otherwise determined to be at high risk
 for coronary obstruction

 -  Patients with low flow/low gradient aortic stenosis

 -  Patients with significant annular or LVOT calcification that could compromise
 procedural success

 -  Pre-existing prosthetic heart valve in any position, or prosthetic ring

 -  Severe aortic, mitral or tricuspid valve regurgitation

 -  Untreated clinically significant coronary artery disease requiring revascularization

 -  Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive
 calcification or severe tortuosity) that would preclude passage of 18 Fr catheters
 from the femoral arterial access to the aorta as evidenced by peripheral MSCT

 -  Need for emergent surgery or intervention other than the investigational procedure