HLT Meridian Valve CE Mark Trial

Not Applicable

Terminated

Brief Summary: 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.

Detailed Description: Prospective, non-randomized, single arm, multi-center CE Mark trial.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Aortic Valve Replacement with HLT® Transcatheter System	HLT® Transcatheter System	Replacement of aortic valve using the HLT® Transcatheter System (HLT System) comprised of The Meridian® II Valve with TriVent™ Anticalcification Treatment and The Pathfinder® II Delivery System

Primary Outcome Measures

Name	Time	Method
All-cause mortality	30 days	Freedom from all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Rate of Adverse Events	Throughout the 5-year follow-up period, assessed annually at a minimum	* All adverse events through the one (1) year follow up period * All Serious Adverse Events through the five (5) year follow up period * Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6 months, 12 months and annually through five (5) years
Post-procedural Valve Performance	14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months	Valve performance will be evaluated by an independent Echo Core Laboratory for the following hemodynamic parameters: * Aortic valve area (AVA) * Aortic valve regurgitation (AR) * Aortic valve gradient (Mean and Peak)
Procedural Device Performance	During the Procedure	Device implant success defined as: Absence of procedural mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20mmHg or peak aortic valve velocity \<3 m/sec, AND no moderate or severe AR)