HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON (HORIZON)

April 28, 2021 updated by: HLT Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Performance Endpoint 1: Procedural Device Performance
Time Frame: Post procedure (day of procedure)

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
Time Frame: 30 days
The primary safety endpoint is all-cause mortality at 30 days.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Performance Endpoint 1: Post-procedural Valve Performance
Time Frame: pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months

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
Time Frame: throughout the 5 year follow up period
All adverse events will be assessed throughout the 5 year follow up period
throughout the 5 year follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HLT Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Axel Linke, MD, University of Leipzig - Herzzcntrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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