HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation (RIVAL - AR EFS)
Primary Purpose
Aortic Regurgitation
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Regurgitation focused on measuring Aortic Valve, Regurgitation, Transcatheter, Replacement
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 *
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
Sites / Locations
- Northwestern University
- The Christ Hospital
- Ohio State University Wexner Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The HLT® Meridian® TAVR Valve
Arm Description
Transcatheter aortic valve replacement with the HLT Meridian TAVR Valve
Outcomes
Primary Outcome Measures
Mortality at 30 days
The primary safety endpoint is all-cause mortality at 30 days
Secondary Outcome Measures
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
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.
Post-procedural Valve Performance - EOA assessed via Echo
• Aortic valve effective orifice area (EOA; cm^2)
Post-procedural Valve Performance- Aortic Regurgitation (AR) assessed via Echo
• Severity of aortic valve regurgitation (AR; graded scale)
Post-procedural Valve Performance - Aortic Valve Gradient assessed via Echo
• Aortic valve gradient (mean and peak; mmHg)
Adverse Events
All adverse events will be assessed throughout the five (5) year follow up period per VARC-3 definitions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05409378
Brief Title
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
Acronym
RIVAL - AR EFS
Official Title
HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
HLT Business Decision
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HLT Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Regurgitation
Keywords
Aortic Valve, Regurgitation, Transcatheter, Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The HLT® Meridian® TAVR Valve
Arm Type
Experimental
Arm Description
Transcatheter aortic valve replacement with the HLT Meridian TAVR Valve
Intervention Type
Device
Intervention Name(s)
The HLT® Meridian® TAVR Valve (Meridian® with TriVentTM Anticalcification Treatment Valve and Pathfinder® Delivery System)
Intervention Description
Aortic valve replacement with the HLT Meridian TAVR Valve to treat aortic regurgitation
Primary Outcome Measure Information:
Title
Mortality at 30 days
Description
The primary safety endpoint is all-cause mortality at 30 days
Time Frame
30-Days
Secondary Outcome Measure Information:
Title
Technical Success - A composite endpoint per VARC-3, defined as meeting the following:
Description
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
Time Frame
Immediately after procedure
Title
Device Success- A composite endpoint per VARC-3, defined as meeting the following:
Description
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.
Time Frame
30 Days
Title
Post-procedural Valve Performance - EOA assessed via Echo
Description
• Aortic valve effective orifice area (EOA; cm^2)
Time Frame
Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
Title
Post-procedural Valve Performance- Aortic Regurgitation (AR) assessed via Echo
Description
• Severity of aortic valve regurgitation (AR; graded scale)
Time Frame
Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
Title
Post-procedural Valve Performance - Aortic Valve Gradient assessed via Echo
Description
• Aortic valve gradient (mean and peak; mmHg)
Time Frame
Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
Title
Adverse Events
Description
All adverse events will be assessed throughout the five (5) year follow up period per VARC-3 definitions
Time Frame
Up to 5 years following enrollment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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 *
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendra Grubb, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Davidson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
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