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HLT Meridian Valve CE Mark Trial (RADIANT CE)

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ClinicalTrials.gov Identifier: NCT03805711
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
HLT Inc.

Brief Summary:
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery.

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

Detailed Description:
Prospective, non-randomized, single arm, multi-center CE Mark trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aortic Valve Replacement with HLT® Transcatheter System
Replacement of aortic valve using the HLT® Transcatheter System (HLT System) comprised of The Meridian® II Valve with TriVent™ Anticalcification Treatment and The Pathfinder® II Delivery System
Device: HLT® Transcatheter System
Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days ]
    Freedom from all-cause mortality


Secondary Outcome Measures :
  1. Procedural Device Performance [ Time Frame: During the Procedure ]

    Device implant success defined as:

    Absence of procedural mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20mmHg or peak aortic valve velocity <3 m/sec, AND no moderate or severe AR)


  2. Post-procedural Valve Performance [ Time Frame: 14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months ]

    Valve performance will be evaluated by an independent Echo Core Laboratory for the following hemodynamic parameters:

    • Aortic valve area (AVA)
    • Aortic valve regurgitation (AR)
    • Aortic valve gradient (Mean and Peak)

  3. Rate of Adverse Events [ Time Frame: Throughout the 5-year follow-up period, assessed annually at a minimum ]
    • All adverse events through the one (1) year follow up period
    • All Serious Adverse Events through the five (5) year follow up period
    • Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6 months, 12 months and annually through five (5) years



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of the following:

    1. Aortic valve area ≤ 1.0 cm^2 or 0.6 cm^2/m^2
    2. Mean aortic valve gradient ≥ 40 mmHg
    3. Peak aortic valve velocity ≥ 4 m/sec
  • Symptoms due to severe aortic stenosis resulting in one of the following:

    1. NYHA Functional Classification of II or greater
    2. Presence of angina
    3. Presence of syncope
  • Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging.
  • Patient is considered intermediate or high risk to undergo surgical aortic valve replacement with one of the following:

    1. Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%
    2. High Surgical Risk: STS-PROM score of ≥ 8%
    3. Documented heart team agreement of risk for surgical aortic valve replacement (SAVR) due to other factors not captured by risk-scores (i.e. frailty or comorbidities)
  • Geographically available, willing to comply with follow up and able to provide written informed consent

Exclusion Criteria:

  • Patients with a coronary height of <10mm, or otherwise determined to be at high risk for coronary obstruction
  • Patients with low flow/low gradient aortic stenosis
  • Patients with significant annular or LVOT calcification that could compromise procedural success
  • Pre-existing prosthetic heart valve in any position, or prosthetic ring
  • Severe aortic, mitral or tricuspid valve regurgitation
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification or severe tortuosity) that would preclude passage of 18 Fr catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
  • Need for emergent surgery or intervention other than the investigational procedure

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 ClinicalTrials.gov identifier (NCT number): NCT03805711


Contacts
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Contact: Angie Swenson 7634167517 Angie.Swenson@HLTMedical.com
Contact: Alison Bernhardt 7634167519 Alison.Bernhardt@hltmedical.com

Locations
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Canada, Quebec
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec Recruiting
Québec City, Quebec, Canada, G1V 4G5
Contact: Josep Rodés-Cabau, MD    418-656-8711    josep.rodes@criucpq.ulaval.ca   
Contact: Claire Gibrat, Ph. D    418-656-8711 ext 3473    claire.gibrat@cruicpq.ulaval.ca   
Principal Investigator: Josep Rodes-Cabau, MD         
Sponsors and Collaborators
HLT Inc.
Investigators
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Principal Investigator: Axel Linke, MD Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik

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Responsible Party: HLT Inc.
ClinicalTrials.gov Identifier: NCT03805711     History of Changes
Other Study ID Numbers: HLT 1801
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
TAVR
TAVI
Aortic Valve

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