HLT
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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.
Enrollment
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Inclusion criteria
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:
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:
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:
Geographically available, willing to comply with follow up and able to provide written informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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