Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial

NCT02799823 | Terminated DMC FDA Device

• 1 other identifier: HLT1501
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

Conditions

Aortic Valve Stenosis

Keywords

aortic stenosis; transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint: Mortality at 30 days

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

  30 days

Secondary Outcomes (3)

• Secondary Performance Endpoint 1: Procedural Device Performance

  1 day

• Secondary Performance Endpoint 2: Post-procedural Valve Performance

  pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months

• Secondary Safety Endpoint 3: Adverse Events

  Throughout the 5 year follow up period

Study Arms (1)

HLT Transcatheter Aortic Valve System

EXPERIMENTAL

Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System

Device: HLT Transcatheter Aortic Valve System

Interventions

HLT Transcatheter Aortic Valve System DEVICE

Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System

HLT Transcatheter Aortic Valve System

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA \<1.0 cm2 or 0.6 cm2/m2, mean aortic valve gradient \>40 mmHg or peak aortic valve velocity \>4 m/sec
• Symptoms due to aortic stenosis resulting in one of the following:
• New York Heart Association (NYHA) Functional Classification of II or greater
• Presence of angina
• Presence of syncope
• Documented aortic valve annular diameter ≥ 21 and ≤ 24 mm (associated perimeter range is 66.0 - 75.4 mm or associated area range of 346 - 452 mm2) measured by the multislice computed tomography (MSCT) Core Lab assessment of pre-procedure imaging.
• Documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities such as:
• Society of Thoracic Surgeons (STS) score of ≥8%
• Frailty as indicated by one of the following:
• Five meter walk test \> 6 seconds
• Katz activities of daily living (ADL) score of 3/6 or less
• Body Mass Index \< 20 kg/m2
• Wheelchair bound, unable to live independently
• Childs Class A or B liver disease

You may not qualify if:

• Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) which could compromise procedural success.
• Patients with a coronary height of \< 10mm, or otherwise determined to be high risk for coronary obstruction
• Patients with low flow/low gradient aortic stenosis
• Patients with significant annular or left ventricular outflow tract (LVOT) calcification that could compromise procedural success
• Pre-existing prosthetic heart valve in any position
• Severe aortic, 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) \< 30%
• Severe pulmonary hypertension with pulmonary systolic pressure greater than two- thirds of systemic pressure
• Hemodynamic instability requiring inotropic drug therapy within the past 14 days
• Untreated clinically significant coronary artery disease requiring revascularization
• Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which precludes safe implant delivery
• Blood dyscrasias defined as leukopenia (White blood cell count \< 1,000 cell/mm3), anemia (hemoglobin \< 9.0 g/dL), thrombocytopenia (platelet count \< 50,000 cells/mm3), history of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• HLT Inc.: lead

Study Sites (5)

MedStar Health

Washington D.C., District of Columbia, 20010, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

The Lindner Center for Research and Education at the Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Baylor Scott & White The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Related Publications (1)

• Rodes-Cabau J, Williams MR, Wijeysundera HC, Kereiakes DJ, Paradis JM, Staniloae C, Saric M, Radhakrishnan S, Wilson RF, Kubo SH. Transcatheter Aortic Valve Replacement With the HLT Meridian Valve. Circ Cardiovasc Interv. 2019 Aug;12(8):e008053. doi: 10.1161/CIRCINTERVENTIONS.119.008053. Epub 2019 Jul 31.

  PMID: 31362540 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Mathew Williams, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

• Dean Kereiakes, MD

  The Christ Hospital

  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: June 3, 2016
• First Posted: June 15, 2016
• Study Start: April 27, 2017
• 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 (5)