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

NCT02838680 | Completed DMC FDA Device

• 1 other identifier: HLT1502
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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 (TAVR)

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 (5)

• Secondary Performance Endpoint 1: Procedural Device Performance

  1 day

• Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Effective Orifice Area)

  1 week, 1, 6, 12, 24, 36, 48 and 60 months

• Secondary Performance Endpoint 2: Post-procedural Valve Performance (Severity of Aortic Valve Regurgitation)

  1 week, 1, 6, 12, 24, 36, 48 and 60 months

• Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Gradient)

  1 week, 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
• Symptomatology due to aortic stenosis resulting in one of the following:
• NYHA Functional Classification of II or greater
• Presence of angina
• Presence of syncope
• Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter
• STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities.
• Geographically available, willing to comply with follow up and able to provide written informed consent

You may not qualify if:

• Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success.
• Patients at high risk for coronary obstruction in the opinion of the investigator (e.g. combination of a coronary height \< 12 mm and coronary sinus diameter \< 30 mm)
• Patients with low flow/low gradient aortic stenosis
• Patients with significant annular calcification (e.g. Agatston score \> 4000)
• Pre-existing prosthetic heart valve in any position, or prosthetic ring
• 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
• 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, in the opinion of the investigator, precludes safe implant delivery
• Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy

Sponsors & Collaborators

• HLT Inc.: lead

Study Sites (2)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

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 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Josep Rodés-Cabau, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

• Harindra Wijeysundera, MD

  Sunnybrook Health Sciences Center

  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: July 13, 2016
• First Posted: July 20, 2016
• Study Start: December 1, 2016
• Primary Completion: April 9, 2018
• Study Completion: October 31, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)