Clinical trial NCT05409378: HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
Official title: HLT® Meridian® TAVR Valve System Early Feasibility Study for Aortic Regurgitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aortic Regurgitation
Keywords: Aortic Valve
Regurgitation
Transcatheter
Replacement
Lead sponsor: HLT Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality at 30 days
timeFrame: 30-Days
Secondary outcomes:
measure: Technical Success - A composite endpoint per VARC-3, defined as meeting the following:
timeFrame: Immediately after procedure
measure: Device Success- A composite endpoint per VARC-3, defined as meeting the following:
timeFrame: 30 Days
measure: Post-procedural Valve Performance - EOA assessed via Echo
timeFrame: Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Post-procedural Valve Performance- Aortic Regurgitation (AR) assessed via Echo
timeFrame: Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Post-procedural Valve Performance - Aortic Valve Gradient assessed via Echo
timeFrame: Discharge (or day 7), 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Adverse Events
timeFrame: Up to 5 years following enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Emory University
name: Kendra Grubb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Charles Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: