HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation (RIVAL - AR EFS)

To evaluate the safety and performance of The Meridian® TAVR Valve in patients with severe aortic regurgitation who present at high risk for aortic valve replacement surgery.

Study Overview

• Status: Withdrawn
• Conditions: Aortic Regurgitation
• Intervention / Treatment: Device: The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angie Sweson; Phone Number: 763-416-7517; Email: Angie.Swenson@hltmedical.com
• Study Contact Backup: Name: Alison Bernhardt; Phone Number: 763-416-7519; Email: Alison.Bernhardt@hltmedical.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Subject has evidence of severe aortic regurgitation as assessed by the independent echo core lab according to an integrative multiparametric based on ASE (American Society of Echocardiography) guidelines considering qualitative and quantitative measures.
2. Symptoms due to severe aortic regurgitation with a NYHA Functional Classification of II or greater
3. Documented aortic valve annular diameter ≥ 21 and ≤ 26 mm (associated perimeter range is 66.0 - 81.7 mm or associated area range of 346 - 531 mm^2) measured by the MSCT Core Lab assessment of pre-procedure imaging
4. Documented heart team agreement of high risk for surgical aortic valve replacement (SAVR)
5. Geographically available, willing to comply with follow-up and able to provide written informed consent.

Exclusion Criteria:

1. Congenital, unicuspid or bicuspid aortic valve which could compromise procedural success
2. Severe mitral or tricuspid valve regurgitation
3. Moderate to severe mitral stenosis
4. Myocardial infarction within the past 30 days*
5. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
6. Left Ventricular Ejection Fraction (LVEF) < 35%
7. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
8. Hemodynamic instability requiring inotropic drug therapy within the past 30 days
9. Untreated clinically significant coronary artery disease requiring revascularization
10. Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure, except for PCI which is performed within 7 days prior to the index procedure*
11. Presence of significant aortic disease such as atheroma, thrombus, dissection (> 50 mm in diameter or which could be considered high risk for dissection) or aneurysm which precludes safe implant delivery
12. Blood dyscrasias defined as leukopenia (White blood cell count < 1,000 cell/mm^3), anemia (hemoglobin < 9.0 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm^3), history of bleeding diathesis or coagulopathy
13. Patient ineligible for or refuses blood transfusions
14. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity) that would preclude passage of 18F catheters from the femoral arterial access to the aorta by the MSCT Core Lab assessment of pre-procedure imaging
15. Active peptic ulcer or gastrointestinal bleeding requiring hospitalization or transfusion within the past 90 days, that would not allow treatment with the protocol antiplatelet regimen post implant *

16. 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*

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

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: The HLT® Meridian® TAVR Valve; Transcatheter aortic valve replacement with the HLT Meridian TAVR Valve	Device: The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System); Aortic valve replacement with the HLT Meridian TAVR Valve to treat aortic regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 30 days	The primary safety endpoint is all-cause mortality at 30 days	30-Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success - A composite endpoint per VARC-3, defined as meeting the following:	Freedom from Mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication	Immediately after procedure
Device Success- A composite endpoint per VARC-3, defined as meeting the following:	Technical Success; Freedom from mortality; Freedom from surgery or intervention related to the device a or to a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation.	30 Days
Post-procedural Valve Performance - EOA assessed via Echo	• Aortic valve effective orifice area (EOA; cm^2)	Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
Post-procedural Valve Performance- Aortic Regurgitation (AR) assessed via Echo	• Severity of aortic valve regurgitation (AR; graded scale)	Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
Post-procedural Valve Performance - Aortic Valve Gradient assessed via Echo	• Aortic valve gradient (mean and peak; mmHg)	Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
Adverse Events	All adverse events will be assessed throughout the five (5) year follow up period per VARC-3 definitions	Up to 5 years following enrollment

Collaborators and Investigators

• Sponsor: HLT Inc.
• Investigators: Principal Investigator: Kendra Grubb, MD, Emory University; Principal Investigator: Charles Davidson, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Replacement; Regurgitation; Transcatheter; Aortic Valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: HLT2101

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