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HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA | Clinical Trials | Clareo Health

WITHDRAWNNA

HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA

NCT02159794•HLT Inc.

Summary

The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

Detailed Description

Prospective, non-randomized, single arm, single-center first-in-man feasibility trial.

Eligibility

Age

75 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 75 years of age or older
•2. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA \<1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient \>40 mmHg or peak aortic valve velocity \>4 m/sec
•3. Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
•4. Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
•5. An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one cardiovascular surgeon and one cardiologist that the co-morbidities not captured by the STS or EuroScore expected to increase the operative mortality risk to \> 15%.
•6. Geographically available, willing to comply with follow up and able to provide written informed consent

Exclusion Criteria

•1. Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success.
•2. Pre-existing prosthetic heart valve in any position, or prosthetic ring
•3. Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
•4. Moderate to severe mitral stenosis
•5. Myocardial infarction within the past 30 days\*
•6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
•7. LVEF \< 30%
•8. Uncontrolled hypertension (i.e. blood pressure at baseline \> 140 mmHg systolic ; or in the opinion of the investigator cannot be controlled by medical therapy).
•9. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
•10. Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months\*
+15 more criteria

Locations (1)

Quebec Heart and Lung Institute

Québec, Quebec, Canada

Key Dates

Start Date

August 1, 2014

Primary Completion Date

December 1, 2014

Completion Date

March 1, 2020

Last Updated

March 26, 2015

Conditions

Severe Aortic Stenosis

Interventions

HLT Transcatheter Aortic Valve System

DEVICE

A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

NCT06136429

Severe Aortic Stenosis

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ACTIVE_NOT_RECRUITINGNA

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

NCT01586910

Severe Aortic Stenosis

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 26, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA

Inclusion Criteria

Exclusion Criteria

A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Alwide Plus China Post-market Clinical Investigation

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System