HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON

Aortic Valve Stenosis Clinical Trial

— HORIZON  

Official title:

HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157142
• Other study ID #: HLT1301
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: October 2019

Study information

• Verified date: April 2021
• Source: HLT Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: October 2019
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Aortic Stenosis

Intervention

Device:
• HLT Transcatheter Aortic Valve System
Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
HLT Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Performance Endpoint 1: Procedural Device Performance	The primary performance endpoint is the Device Success defined as: Absence of procedural mortality AND; Correct positioning of a single HLT Valve into the proper anatomical location AND; Intended performance of the HLT Valve (no prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak aortic valve velocity < 3 m/sec, AND no moderate or severe aortic valve regurgitation)	Post procedure (day of procedure)
Primary	Primary Safety Endpoint 2: Mortality at 30 days	The primary safety endpoint is all-cause mortality at 30 days.	30 days
Secondary	Secondary Performance Endpoint 1: Post-procedural Valve Performance	The HLT Valve performance will be evaluated by the following parameters with echocardiograms obtained at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months: Aortic valve effective orifice area (EOA); Severity of aortic valve regurgitation (AR); Aortic valve gradient	pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months
Secondary	Secondary Safety Endpoint 2: Adverse Events	All adverse events will be assessed throughout the 5 year follow up period	throughout the 5 year follow up period