HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON

NCT02157142 | Completed DMC FDA Device

• 1 other identifier: HLT1301
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Aortic Stenosis; Aortic Valve Stenosis

Keywords

Severe aortic stenosis; Aortic valve stenosis; Transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (2)

• Primary Performance Endpoint 1: Procedural Device Performance

  The primary performance endpoint is the Device Success defined as: * Absence of procedural mortality AND * Correct positioning of a single HLT Valve into the proper anatomical location AND * Intended performance of the HLT Valve (no prosthesis- patient mismatch and mean aortic valve gradient \< 20 mmHg or peak aortic valve velocity \< 3 m/sec, AND no moderate or severe aortic valve regurgitation)

  Post procedure (day of procedure)

• Primary Safety Endpoint 2: Mortality at 30 days

  The primary safety endpoint is all-cause mortality at 30 days.

  30 days

Secondary Outcomes (2)

• Secondary Performance Endpoint 1: Post-procedural Valve Performance

  pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months

• Secondary Safety Endpoint 2: Adverse Events

  throughout the 5 year follow up period

Study Arms (1)

HLT Transcatheter Aortic Valve System

EXPERIMENTAL

Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System

Device: HLT Transcatheter Aortic Valve System

Interventions

HLT Transcatheter Aortic Valve System DEVICE

Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System

HLT Transcatheter Aortic Valve System

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• 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
• Symptomatology due to aortic stenosis resulting in a New York Heart Association (NYHA) Functional Classification of II or greater
• Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
• 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%.
• Geographically available, willing to comply with follow up and able to provide written informed consent

You may not qualify if:

• 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.
• Pre-existing prosthetic heart valve in any position, or prosthetic ring
• Severe (Grade 3 to 4) aortic, mitral or tricuspid valve regurgitation
• Moderate to severe mitral stenosis
• Myocardial infarction within the past 30 days\*
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• LVEF \< 30%
• Uncontrolled hypertension (i.e. blood pressure at baseline \> 140 mmHg systolic; or in the opinion of the investigator cannot be controlled by medical therapy).
• Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
• Hemodynamic instability requiring inotropic drug therapy within the past 14 days or mechanical support within the past 6 months\*
• Untreated clinically significant coronary artery disease requiring revascularization
• Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
• Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
• Patient ineligible for or refuses blood transfusions
• Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or small vessels) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT

Sponsors & Collaborators

• HLT Inc.: lead

Study Sites (1)

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Axel Linke, MD

  University of Leipzig - Herzzcntrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 5, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2019
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

DE (1)