Brief Title
HLT Meridian Valve CE Mark Trial
Official Title
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial
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.
Study Type
Interventional
Primary Outcome
All-cause mortality
Secondary Outcome
Procedural Device Performance
Condition
Aortic Valve Stenosis
Intervention
HLT® Transcatheter System
Study Arms / Comparison Groups
Aortic Valve Replacement with HLT® Transcatheter System
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1
Start Date
July 12, 2019
Completion Date
September 20, 2019
Primary Completion Date
September 20, 2019
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Axel Linke, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03805711
Organization ID
HLT 1801
Responsible Party
Sponsor
Study Sponsor
HLT Inc.
Study Sponsor
Axel Linke, MD, Principal Investigator, Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik
Verification Date
May 2020