HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA
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.
Prospective, non-randomized, single arm, single-center first-in-man feasibility trial.
Inclusion Criteria:

 1. 75 years of age or older

 2. 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

 3. Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA)
 Functional Classification of II or greater

 4. Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT

 5. An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one
 cardiovascular surgeon and one cardiologist that the co-morbidities not captured by
 the STS or EuroScore expected to increase the operative mortality risk to > 15%.

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

 Exclusion Criteria:

 1. Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve
 eccentricity (calcific or otherwise) that in the opinion of the investigator could
 compromise procedural success.

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

 3. Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation

 4. Moderate to severe mitral stenosis

 5. Myocardial infarction within the past 30 days*

 6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation

 7. LVEF < 30%

 8. Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic ; or in
 the opinion of the investigator cannot be controlled by medical therapy).

 9. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds
 of systemic pressure

 10. Hemodynamic instability requiring inotropic drug therapy within the past 14 days or
 mechanical support within the past 6 months*

 11. Untreated clinically significant coronary artery disease requiring revascularization

 12. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which,
 in the opinion of the investigator, precludes safe implant delivery

 13. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia,
 history of bleeding diathesis or coagulopathy

 14. Patient ineligible for or refuses blood transfusions

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

 16. Active peptic ulcer or gastrointestinal bleeding within the past 90 days*

 17. Stroke or transient ischemic attack within past 6 months*

 18. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage
 renal disease requiring chronic dialysis

 19. Active infection requiring ongoing treatment

 20. Need for emergent surgery or intervention other than the investigational procedure

 21. Any therapeutic invasive cardiac procedure performed or planned to perform within 30
 days of the index procedure, (or 6 months for drug eluting coronary stent or
 biventricular pacemaker implantation)*

 22. Hypersensitivity or contraindication to procedural medication and device materials
 (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated

 23. Life expectancy < 1 year due to non-cardiac co-morbid conditions

 24. Currently participating in any investigational drug or device studies that may
 confound the results of this study

 25. History of any cognitive or mental health status that would interfere with study
 participation * At the time of procedure, if a subject's medical status has changed
 since enrollment, the subject shall be re-evaluated for eligibility