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HLT Meridian Valve CE Mark Trial (RADIANT CE)

Primary Purpose

Aortic Valve Stenosis

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

HLT® Transcatheter System

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVR, TAVI, Aortic Valve

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aortic Valve Replacement with HLT® Transcatheter System

Arm 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

Outcomes

Primary Outcome Measures

All-cause mortality

Freedom from all-cause mortality

Secondary Outcome Measures

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)

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)

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

Full Information

NCT ID

NCT03805711

First Posted

January 9, 2019

Last Updated

May 15, 2020

Sponsor

HLT Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03805711

Brief Title

HLT Meridian Valve CE Mark Trial

Acronym

RADIANT CE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision to stop enrollment.

Study Start Date

July 12, 2019 (Actual)

Primary Completion Date

September 20, 2019 (Actual)

Study Completion Date

September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HLT Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

Keywords

Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVR, TAVI, Aortic Valve

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aortic Valve Replacement with HLT® Transcatheter System

Arm Type

Experimental

Arm 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

Intervention Type

Device

Intervention Name(s)

HLT® Transcatheter System

Intervention Description

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%).

Primary Outcome Measure Information:

Title

All-cause mortality

Description

Freedom from all-cause mortality

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Procedural Device Performance

Description

Time Frame

During the Procedure

Title

Post-procedural Valve Performance

Description

Time Frame

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

Title

Rate of Adverse Events

Description

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Axel Linke, MD

Organizational Affiliation

Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Québec City

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

HLT Meridian Valve CE Mark Trial

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