HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation

NCT05409378 | Withdrawn DMC FDA Device

• 1 other identifier: HLT2101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Aortic Regurgitation

Keywords

Aortic Valve; Regurgitation; Transcatheter; Replacement

Outcome Measures

Primary Outcomes (1)

• Mortality at 30 days

  The primary safety endpoint is all-cause mortality at 30 days

  30-Days

Secondary Outcomes (6)

• Technical Success - A composite endpoint per VARC-3, defined as meeting the following:

  Immediately after procedure

• Device Success- A composite endpoint per VARC-3, defined as meeting the following:

  30 Days

• Post-procedural Valve Performance - EOA assessed via Echo

  Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months

• Post-procedural Valve Performance- Aortic Regurgitation (AR) assessed via Echo

  Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months

• Post-procedural Valve Performance - Aortic Valve Gradient assessed via Echo

  Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months

Study Arms (1)

The HLT® Meridian® TAVR Valve

EXPERIMENTAL

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)

Interventions

The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System) DEVICE

Aortic valve replacement with the HLT Meridian TAVR Valve to treat aortic regurgitation

The HLT® Meridian® TAVR Valve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Symptoms due to severe aortic regurgitation with a NYHA Functional Classification of II or greater
• 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
• Documented heart team agreement of high risk for surgical aortic valve replacement (SAVR)
• Geographically available, willing to comply with follow-up and able to provide written informed consent.

You may not qualify if:

• Congenital, unicuspid or bicuspid aortic valve which could compromise procedural success
• Severe mitral or tricuspid valve regurgitation
• Moderate to severe mitral stenosis
• Myocardial infarction within the past 30 days\*
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Left Ventricular Ejection Fraction (LVEF) \< 35%
• Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
• Hemodynamic instability requiring inotropic drug therapy within the past 30 days
• Untreated clinically significant coronary artery disease requiring revascularization
• 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\*
• 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
• 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
• Patient ineligible for or refuses blood transfusions
• 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
• 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 \*

Sponsors & Collaborators

• HLT Inc.: lead

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Aortic Valve Insufficiency; Gastroesophageal Reflux

Interventions

Meridians

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Officials

• Kendra Grubb, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Charles Davidson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 8, 2022
• Study Start: July 8, 2022
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)