Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
• 70 years of age or older
• Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA \<1.0 cm2 or 0.6 cm2/m2, mean aortic valve gradient \>40 mmHg or peak aortic valve velocity \>4 m/sec
• Symptoms due to aortic stenosis resulting in one of the following:
∙ New York Heart Association (NYHA) Functional Classification of II or greater
‣ Presence of angina
‣ Presence of syncope
• Documented aortic valve annular diameter ≥ 21 and ≤ 24 mm (associated perimeter range is 66.0 - 75.4 mm or associated area range of 346 - 452 mm2) measured by the multislice computed tomography (MSCT) Core Lab assessment of pre-procedure imaging.
• Documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities such as:
‣ Society of Thoracic Surgeons (STS) score of ≥8%
⁃ Frailty as indicated by one of the following:
• Five meter walk test \> 6 seconds
∙ Katz activities of daily living (ADL) score of 3/6 or less
∙ Body Mass Index \< 20 kg/m2
∙ Wheelchair bound, unable to live independently
⁃ Childs Class A or B liver disease
⁃ Severe lung disease (need for supplemental oxygen, forced expiratory volume at one second (FEV1) \< 50% of predicted, diffusing capacity of the lungs for carbon monoxide (DLCO) \< 60%, or other evidence of severe pulmonary dysfunction
⁃ Previous coronary artery bypass graft(s) at risk for re-operation
⁃ Serum albumin \< 3.5 g/dL
⁃ Other evidence that subject is at high risk for surgical valve replacement by one of the following:
• Hostile chest
∙ Porcelain aorta
∙ Severe pulmonary hypertension (\> 60 mmHg)
∙ Prior chest radiation therapy
∙ Neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement
∙ Orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement
• Geographically available, willing to comply with follow up and able to provide written informed consent