HLT Meridian Valve CE Mark Trial

Aortic Valve Stenosis Clinical Trial

— RADIANT CE  

Official title:

Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03805711
• Other study ID #: HLT 1801
• Status: Terminated
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: September 20, 2019

Study information

• Verified date: May 2020
• Source: HLT Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• 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%).

Locations

Country	Name	City	State
Canada	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
HLT Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Freedom from all-cause mortality	30 days
Secondary	Procedural Device Performance	Device implant success defined as: Absence of procedural mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20mmHg or peak aortic valve velocity <3 m/sec, AND no moderate or severe AR)	During the Procedure
Secondary	Post-procedural Valve Performance	Valve performance will be evaluated by an independent Echo Core Laboratory for the following hemodynamic parameters: Aortic valve area (AVA); Aortic valve regurgitation (AR); Aortic valve gradient (Mean and Peak)	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
Secondary	Rate of Adverse Events	All adverse events through the one (1) year follow up period; All Serious Adverse Events through the five (5) year follow up period; Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6 months, 12 months and annually through five (5) years	Throughout the 5-year follow-up period, assessed annually at a minimum