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Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial (RADIANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02799823
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):
HLT Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: HLT Transcatheter Aortic Valve System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial
Actual Study Start Date : April 27, 2017
Actual Primary Completion Date : April 14, 2018
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HLT Transcatheter Aortic Valve System
Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System
Device: HLT Transcatheter Aortic Valve System
Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System

Primary Outcome Measures :
  1. Primary Endpoint: Mortality at 30 days [ Time Frame: 30 days ]
    The primary safety endpoint is all-cause mortality at 30 days.

Secondary Outcome Measures :
  1. Secondary Performance Endpoint 1: Procedural Device Performance [ Time Frame: 1 day ]

    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)

  2. Secondary Performance Endpoint 2: Post-procedural Valve Performance [ Time Frame: pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months ]

    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

  3. Secondary Safety Endpoint 3: Adverse Events [ Time Frame: Throughout the 5 year follow up period ]
    All adverse events will be assessed throughout the 5 year follow up period.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 70 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 one of the following:

    1. NYHA Functional Classification of II or greater
    2. Presence of angina
    3. Presence of syncope
  4. Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter
  5. STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities.
  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. Patients at high risk for coronary obstruction in the opinion of the investigator (e.g. combination of a coronary height < 12 mm and coronary sinus diameter < 30 mm)
  3. Patients with low flow/low gradient aortic stenosis
  4. Patients with significant annular calcification (e.g. Agatston score > 4000)
  5. Pre-existing prosthetic heart valve in any position, or prosthetic ring
  6. Severe aortic, mitral or tricuspid valve regurgitation
  7. Moderate to severe mitral stenosis
  8. Myocardial infarction within the past 30 days*
  9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  10. LVEF < 30%
  11. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
  12. Hemodynamic instability requiring inotropic drug therapy within the past 14 days
  13. Untreated clinically significant coronary artery disease requiring revascularization
  14. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
  15. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
  16. Patient ineligible for or refuses blood transfusions
  17. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or vessels < 6 mm) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
  18. Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
  19. Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic attack) within past 6 month, or treatment of carotid stenosis within past two months*
  20. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
  21. Active infection requiring ongoing treatment
  22. Need for emergent surgery or intervention other than the investigational procedure
  23. Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure, except for PCI which is within 7 days of the index procedure*
  24. Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
  25. Life expectancy < 1 year due to non-cardiac co-morbid conditions
  26. Currently participating in any investigational drug or device studies that may confound the results of this study
  27. History of any cognitive or mental health status that would interfere with study participation
  28. Following surgical consultation, patient is deemed inoperable in the event that surgical intervention is required after HLT valve implantation attempt.

    • At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02799823

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United States, Indiana
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
NYU Langone Medical Center
New York, New York, United States, 10016
United States, Ohio
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
HLT Inc.
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Study Chair: Mathew Williams, MD NYU Langone Medical Center
Principal Investigator: James Hermiller, MD St. Vincent Heart Center of Indian

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Responsible Party: HLT Inc. Identifier: NCT02799823     History of Changes
Other Study ID Numbers: HLT1501
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by HLT Inc.:
aortic stenosis
transcatheter aortic valve replacement

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction