Aortic RegurgitationRIVAL - AR EFSNCT05409378
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
A study testing The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System) in people with Aortic Regurgitation, run by HLT Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Regurgitation
- What is being tested?
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jul 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 17Show fewer
- 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 *
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
The Christ Hospital
Cincinnati, Ohio, 45219
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
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
- Being tested
- The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
- Keywords
- Aortic Valve, Regurgitation, Transcatheter, Replacement
- Medical subject headings
- Aortic Valve Insufficiency, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| The HLT® Meridian® TAVR Valve | Experimental | Transcatheter aortic valve replacement with the HLT Meridian TAVR Valve Receives: Device: The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 days
The primary safety endpoint is all-cause mortality at 30 days
Measured: 30-Days
Secondary outcomes (6)
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
Measured: 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.
Measured: 30 Days
Post-procedural Valve Performance - EOA assessed via Echo
- Aortic valve effective orifice area (EOA; cm^2)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Up to 5 years following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start8 Jul 2022
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Why it stopped: HLT Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kendra Grubb, MD, Principal investigator, Emory UniversityCharles Davidson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409378
- Sponsor's protocol ID
- HLT2101
- Acronym
- RIVAL - AR EFS
- Status last verified
- May 2023
- First submitted
- 24 May 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
- ClinicalTrials.gov ID
- NCT05409378
- Acronym / sponsor ID
- RIVAL - AR EFS / HLT2101
- Conditions
- Aortic Regurgitation
- Keywords
- Aortic Valve, Regurgitation, Transcatheter, Replacement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: HLT Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HLT Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The HLT® Meridian® TAVR Valve | Experimental | Device: The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)Transcatheter aortic valve replacement with the HLT Meridian TAVR Valve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | The HLT® Meridian® TAVR Valve |
Primary outcome
Mortality at 30 days
Time frame: 30-Days
The primary safety endpoint is all-cause mortality at 30 days
6 secondary outcomes
Technical Success - A composite endpoint per VARC-3, defined as meeting the following:
Time frame: Immediately after procedure
Device Success- A composite endpoint per VARC-3, defined as meeting the following:
Time frame: 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
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
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
Adverse Events
Time frame: Up to 5 years following enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kendra Grubb, MD principal investigator
Emory University
Charles Davidson, MD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System) in people with Aortic Regurgitation, run by HLT Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 30 days (time frame: 30-Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.