AzTrials
AzTrials

Aortic Valve StenosisRADIANTNCT02799823

Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial

A study testing HLT Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by HLT Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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 70 years and older
Conditions the study is for
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
11 participants
Where
5 sitesUnited States
Study dates
27 Apr 2017to 20 Jan 2023
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 70 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
  • Symptoms due to aortic stenosis resulting in one of the following:
  • New York Heart Association (NYHA) Functional Classification of II or greater
  • Presence of angina
  • Presence of syncope
Show all 26Show fewer
  • Documented aortic valve annular diameter ≥ 21 and ≤ 24 mm (associated perimeter range is 66.0 - 75.4 mm or associated area range of 346 - 452 mm2) measured by the multislice computed tomography (MSCT) Core Lab assessment of pre-procedure imaging.
  • Documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities such as:
  • Society of Thoracic Surgeons (STS) score of ≥8%
  • Frailty as indicated by one of the following:
  • Five meter walk test > 6 seconds
  • Katz activities of daily living (ADL) score of 3/6 or less
  • Body Mass Index < 20 kg/m2
  • Wheelchair bound, unable to live independently
  • Childs Class A or B liver disease
  • Severe lung disease (need for supplemental oxygen, forced expiratory volume at one second (FEV1) < 50% of predicted, diffusing capacity of the lungs for carbon monoxide (DLCO) < 60%, or other evidence of severe pulmonary dysfunction
  • Previous coronary artery bypass graft(s) at risk for re-operation
  • Serum albumin < 3.5 g/dL
  • Other evidence that subject is at high risk for surgical valve replacement by one of the following:
  • Hostile chest
  • Porcelain aorta
  • Severe pulmonary hypertension (> 60 mmHg)
  • Prior chest radiation therapy
  • Neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement
  • Orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement
  • 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) which could compromise procedural success.
  • Patients with a coronary height of < 10mm, or otherwise determined to be high risk for coronary obstruction
  • Patients with low flow/low gradient aortic stenosis
  • Patients with significant annular or left ventricular outflow tract (LVOT) calcification that could compromise procedural success
  • Pre-existing prosthetic heart valve in any position
  • Severe aortic, mitral or tricuspid valve regurgitation
Show all 31Show fewer
  • Moderate to severe mitral stenosis
  • Myocardial infarction within the past 30 days*
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Left Ventricular Ejection Fraction (LVEF) < 30%
  • 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
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which precludes safe implant delivery
  • Blood dyscrasias defined as leukopenia (White blood cell count < 1,000 cell/mm3), anemia (hemoglobin < 9.0 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm3), 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) that would preclude passage of 18 French (18F) 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, that would not allow treatment with the protocol antiplatelet regimen post implant *
  • Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic attack) within past 6 months, or treatment of carotid stenosis within past two months*
  • Renal disease as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease
  • Active infection (including endocarditis) 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, except for percutaneous coronary intervention (PCI) which is performed within 7 days prior to the index procedure*
  • Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately premedicated
  • 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
  • Following surgical consultation, patient is deemed inoperable in the event that surgical intervention is required after Meridian valve implantation
  • Patients with a history of hypertrophic cardiomyopathy
  • Aortic root angle ≥ 70˚ as determined by the MSCT Core Lab assessment of pre- procedure imaging
  • Unfavorable left ventricular anatomy (e.g., size or shape) as evidenced by pre- procedure imaging * 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

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • The Lindner Center for Research and Education at the Christ Hospital

    Cincinnati, Ohio, 45219

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • NYU Langone Medical Center

    New York, New York, 10016

  • Baylor Scott & White The Heart Hospital Plano

    Plano, Texas, 75093

  • MedStar Health

    Washington D.C., District of Columbia, 20010

Other trials in United States

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.

Being tested
HLT Transcatheter Aortic Valve System
Keywords
aortic 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 HLT Transcatheter Aortic Valve System

Study groups in NCT02799823
Study groupRoleWhat they receive
HLT Transcatheter Aortic Valve SystemExperimentalTranscatheter aortic valve replacement with 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.

  1. Primary Endpoint: Mortality at 30 days

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

    Measured: 30 days

Secondary outcomes (3)

  1. Secondary Performance Endpoint 1: Procedural Device Performance

    The secondary performance endpoint is Device Success defined as:

    • Absence of procedural mortality AND
    • Correct positioning of a single Valve into the proper anatomical location AND
    • Intended performance of the Valve (no severe prosthesis-patient mismatch and clinically acceptable gradient) AND no moderate or severe aortic valve regurgitation)

    Measured: 1 day

  2. Secondary Performance Endpoint 2: Post-procedural Valve Performance

    The 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, 1, 6, 12, 24, 36, 48 and 60 months

  3. Secondary Safety Endpoint 3: 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.

  1. First posted15 Jun 2016 (estimated)
  2. Study start27 Apr 2017
  3. Primary completion20 Jan 2023
  4. Study completion20 Jan 2023

Why it stopped: HLT Business Decision

Resources

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799823
Sponsor's protocol ID
HLT1501
Acronym
RADIANT
Status last verified
May 2023
First submitted
3 Jun 2016
Last updated
31 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Rodes-Cabau J, Williams MR, Wijeysundera HC, Kereiakes DJ, Paradis JM, Staniloae C, Saric M, Radhakrishnan S, Wilson RF, Kubo SH. Transcatheter Aortic Valve Replacement With the HLT Meridian Valve. Circ Cardiovasc Interv. 2019 Aug;12(8):e008053. doi: 10.1161/CIRCINTERVENTIONS.119.008053. Epub 2019 Jul 31.

    PubMed 31362540

Questions about this trial

What is this clinical trial studying?

A study testing HLT Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by HLT Inc. at 5 sites in United States.

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 26 inclusion and 31 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: stopped early, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 was stopped early (reason given: HLT Business Decision). Results are not available in the source record.

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 Endpoint: Mortality at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02799823, which also lists 1 linked publication.

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 31 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in