HLT Meridian Valve CE Mark Trial

NCT ID: NCT03805711

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-12
• Study Completion Date: 2019-09-20

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.

Detailed Description

Prospective, non-randomized, single arm, multi-center CE Mark trial.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aortic Valve Replacement with HLT® Transcatheter System

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

Group Type: EXPERIMENTAL

HLT® Transcatheter System

Intervention Type: 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%).

Interventions

HLT® Transcatheter System

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%).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of the following:

1. Aortic valve area ≤ 1.0 cm^2 or 0.6 cm^2/m^2

2. Mean aortic valve gradient ≥ 40 mmHg

3. Peak aortic valve velocity ≥ 4 m/sec

• Symptoms due to severe aortic stenosis resulting in one of the following:

1. NYHA Functional Classification of II or greater

2. Presence of angina

3. 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:

1. Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%

2. High Surgical Risk: STS-PROM score of ≥ 8%

3. 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HLT Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Linke, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik

Locations

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

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

HLT 1801

Identifier Type: -

Identifier Source: org_study_id