HLT Meridian Valve CE Mark Trial

NCT03805711 | Terminated DMC FDA Device

• 1 other identifier: HLT 1801
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Stenosis; Transcatheter Aortic Valve Replacement; TAVR; TAVI; Aortic Valve

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Freedom from all-cause mortality

  30 days

Secondary Outcomes (3)

• Procedural Device Performance

  During the Procedure

• Post-procedural Valve Performance

  14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months

• Rate of Adverse Events

  Throughout the 5-year follow-up period, assessed annually at a minimum

Study Arms (1)

Aortic Valve Replacement with HLT® Transcatheter System

EXPERIMENTAL

Replacement of aortic valve using the HLT® Transcatheter System (HLT System) comprised of The Meridian® II Valve with TriVent™ Anticalcification Treatment and The Pathfinder® II Delivery System

Device: HLT® Transcatheter System

Interventions

HLT® Transcatheter System DEVICE

Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).

Aortic Valve Replacement with HLT® Transcatheter System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of the following:
• Aortic valve area ≤ 1.0 cm\^2 or 0.6 cm\^2/m\^2
• Mean aortic valve gradient ≥ 40 mmHg
• Peak aortic valve velocity ≥ 4 m/sec
• Symptoms due to severe aortic stenosis resulting in one of the following:
• NYHA Functional Classification of II or greater
• Presence of angina
• Presence of syncope
• Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging.
• Patient is considered intermediate or high risk to undergo surgical aortic valve replacement with one of the following:
• Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%
• High Surgical Risk: STS-PROM score of ≥ 8%
• Documented heart team agreement of risk for surgical aortic valve replacement (SAVR) due to other factors not captured by risk-scores (i.e. frailty or comorbidities)
• Geographically available, willing to comply with follow up and able to provide written informed consent

You may not qualify if:

• Patients with a coronary height of \<10mm, or otherwise determined to be at high risk for coronary obstruction
• Patients with low flow/low gradient aortic stenosis
• Patients with significant annular or LVOT calcification that could compromise procedural success
• Pre-existing prosthetic heart valve in any position, or prosthetic ring
• Severe aortic, mitral or tricuspid valve regurgitation
• Untreated clinically significant coronary artery disease requiring revascularization
• Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification or severe tortuosity) that would preclude passage of 18 Fr catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
• Need for emergent surgery or intervention other than the investigational procedure

Sponsors & Collaborators

• HLT Inc.: lead

Study Sites (1)

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Axel Linke, MD

  Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik

  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: January 9, 2019
• First Posted: January 16, 2019
• Study Start: July 12, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)