HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON (HORIZON)

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 Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Severe Aortic Stenosis
• Intervention / Treatment: Device: HLT Transcatheter Aortic Valve System

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • University of Leipzig - Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLT Transcatheter Aortic Valve System; Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System	Device: HLT Transcatheter Aortic Valve System; Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Safety Endpoint 2: Mortality at 30 days	The primary safety endpoint is all-cause mortality at 30 days.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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

Collaborators and Investigators

• Sponsor: HLT Inc.
• Investigators: Principal Investigator: Axel Linke, MD, University of Leipzig - Herzzcntrum

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 3, 2014
• First Posted (Estimate): June 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Aortic valve stenosis; Transcatheter aortic valve replacement; Severe aortic stenosis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: HLT1301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes