HLT Meridian Valve CE Mark Trial (RADIANT CE)

Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: HLT® Transcatheter System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec City, Quebec, Canada, G1V 4G5
      • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Freedom from all-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Device Performance	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)	During the Procedure
Post-procedural Valve Performance	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)	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
Rate of Adverse Events	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	Throughout the 5-year follow-up period, assessed annually at a minimum

Collaborators and Investigators

• Sponsor: HLT Inc.
• Investigators: Principal Investigator: Axel Linke, MD, Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): September 20, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Transcatheter Aortic Valve Replacement; TAVI; TAVR; Aortic Valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: HLT 1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes