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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.

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE July 12, 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
All-cause mortality [ Time Frame: 30 days ]
Freedom from all-cause mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03805711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HLT Meridian Valve CE Mark Trial
Official Title  ICMJE Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial
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.
Detailed Description Prospective, non-randomized, single arm, multi-center CE Mark trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE 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%).
Study Arms  ICMJE 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
Intervention: Device: HLT® Transcatheter System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angie Swenson 7634167517 Angie.Swenson@HLTMedical.com
Contact: Alison Bernhardt 7634167519 Alison.Bernhardt@hltmedical.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03805711
Other Study ID Numbers  ICMJE HLT 1801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HLT Inc.
Study Sponsor  ICMJE HLT Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Axel Linke, MD Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik
PRS Account HLT Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP