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

May 29, 2023 updated by: HLT Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality at 30 days
Time Frame: 30-Days
The primary safety endpoint is all-cause mortality at 30 days
30-Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical Success - A composite endpoint per VARC-3, defined as meeting the following:
Time Frame: Immediately after procedure
  • 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:
Time Frame: 30 Days
  • 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
Time Frame: Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
• 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
Time Frame: Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
• 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
Time Frame: Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
• Aortic valve gradient (mean and peak; mmHg)
Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
Adverse Events
Time Frame: Up to 5 years following enrollment
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HLT Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kendra Grubb, MD, Emory University
  • Principal Investigator: Charles Davidson, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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