Brief Title
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
Official Title
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
Brief Summary
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.
Study Type
Interventional
Primary Outcome
Primary Performance Endpoint 1: Procedural Device Performance
Secondary Outcome
Secondary Performance Endpoint 1: Post-procedural Valve Performance
Condition
Severe Aortic Stenosis
Intervention
HLT Transcatheter Aortic Valve System
Study Arms / Comparison Groups
HLT Transcatheter Aortic Valve System
Description: Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
4
Start Date
August 2014
Completion Date
October 2019
Primary Completion Date
December 2014
Eligibility Criteria
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.
Gender
All
Ages
75 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Axel Linke, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02157142
Organization ID
HLT1301
Responsible Party
Sponsor
Study Sponsor
HLT Inc.
Study Sponsor
Axel Linke, MD, Principal Investigator, University of Leipzig - Herzzcntrum
Verification Date
July 2020