Severe Aortic StenosisHORIZONNCT02157142
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
A study testing HLT Transcatheter Aortic Valve System in people with Severe Aortic Stenosis and Aortic Valve Stenosis, run by HLT Inc. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Severe Aortic Stenosis, Aortic Valve Stenosis
- What is being tested?
- HLT Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years of age or older
- 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
- Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
- Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
- 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%.
- Geographically available, willing to comply with follow up and able to provide written informed consent
Who cannot join
- 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.
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
- Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
- Moderate to severe mitral stenosis
- Myocardial infarction within the past 30 days*
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Show all 26Show fewer
- LVEF < 30%
- Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic; or in the opinion of the investigator cannot be controlled by medical therapy).
- Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
- Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months*
- Untreated clinically significant coronary artery disease requiring revascularization
- Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
- Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
- Patient ineligible for or refuses blood transfusions
- 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
- Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
- Stroke or transient ischemic attack within past 6 months*
- Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
- Active infection requiring ongoing treatment
- Need for emergent surgery or intervention other than the investigational procedure
- 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)*
- Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
- Life expectancy < 1 year due to non-cardiac co-morbid conditions
- Currently participating in any investigational drug or device studies that may confound the results of this study
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Severe Aortic Stenosis, Aortic Valve Stenosis
- Being tested
- HLT Transcatheter Aortic Valve System
- Keywords
- Severe aortic stenosis, Aortic valve stenosis, Transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLT Transcatheter Aortic Valve SystemDevice
Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System
| Study group | Role | What they receive |
|---|---|---|
| HLT Transcatheter Aortic Valve System | Experimental | Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System Receives: Device: HLT Transcatheter Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Post procedure (day of procedure)
Primary Safety Endpoint 2: Mortality at 30 days
The primary safety endpoint is all-cause mortality at 30 days.
Measured: 30 days
Secondary outcomes (2)
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
Measured: 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
Measured: throughout the 5 year follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- HLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Linke, MD, Principal investigator, University of Leipzig - Herzzcntrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157142
- Sponsor's protocol ID
- HLT1301
- Acronym
- HORIZON
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2014
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
- ClinicalTrials.gov ID
- NCT02157142
- Acronym / sponsor ID
- HORIZON / HLT1301
- Conditions
- Severe Aortic Stenosis, Aortic Valve Stenosis
- Keywords
- Severe aortic stenosis, Aortic valve stenosis, Transcatheter aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- HLT Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 5 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLT Transcatheter Aortic Valve System | Experimental | Device: HLT Transcatheter Aortic Valve SystemTranscatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 75 years of age or older
- 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
- Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
- Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
- 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%.
Key exclusion criteria (26 listed)
- 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.
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
- Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
- Moderate to severe mitral stenosis
- Myocardial infarction within the past 30 days*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLT Transcatheter Aortic Valve SystemTranscatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System | Device | HLT Transcatheter Aortic Valve System |
Primary outcome
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)
Primary Safety Endpoint 2: Mortality at 30 days
Time frame: 30 days
The primary safety endpoint is all-cause mortality at 30 days.
2 secondary outcomes
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
Secondary Safety Endpoint 2: Adverse Events
Time frame: throughout the 5 year follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Linke, MD principal investigator
University of Leipzig - Herzzcntrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLT Transcatheter Aortic Valve System in people with Severe Aortic Stenosis and Aortic Valve Stenosis, run by HLT Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Performance Endpoint 1: Procedural Device Performance (time frame: Post procedure (day of procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.