Heart Leaflet Technologies Valve Study

Study Overview
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Brief Summary
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The study will be conducted in patients who are undergoing surgical aortic valve replacement on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to removal of the valve, the native valve will be dilated using a standard valve dilation balloon. The Heart Leaflet Technologies(HLT- Heart Leaflet Technologies Inc.) aortic valve device will be released in the native valve and measurements will be taken of the device relative to the anatomic structures of the heart. Once completed, the implant is removed from the native valve and the surgical valve replacement procedure is completed. The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate for patients with aortic valve stenosis.

Detailed Description
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Aortic valve stenosis is a disease in which the leaflets of the aortic valve become scarred and calcified. This leads to a severe narrowing of the valve orifice, which causes chest pain, heart failure and eventually death. The condition is currently treated with open chest surgical valve replacement on cardiopulmonary bypass. Heart Leaflet Technologies has developed an aortic valve prosthesis that can be delivered to the stenotic aortic valve through a catheter inserted in the femoral artery. The purpose of this study is to confirm that the dimensions of the HLT valve are appropriate for patients with aortic valve stenosis. There is no animal model of aortic valve stenosis. Heart Leaflet Technologies has performed extensive device geometry and deployment testing on fixed cadaveric hearts with calcified cusps and aortic stenosis. HLT has also performed a number of preclinical animal experiments to verify deliverability and device function in vivo.

Official Title
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Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve

Conditions
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Aortic Valve Stenosis, Endovascular Aortic Valve Replacement

Intervention / Treatment
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* Procedure: surgical replacement of the aortic stenotic valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing aortic valve replacement for aortic valve stenosis with a preoperative valve area < 0.9 cm2. A preoperative echocardiogram where the aortic annulus diameter can be measured and is between 19 and 25 mm internal diameter. Age 75 to 80 years Exclusion Criteria: Emergency valve surgery Significant ascending aortic disease (atheroma, extensive calcification, dissection) as assessed by the operating surgeon Ostial coronary obstruction > 25% diameter stenosis

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Patients undergoing surgical aortic valve replacement on cardiopulmonary bypass. | Procedure: surgical replacement of the aortic stenotic valve<br>* Prior to surgical removal of the aortic valve, the native valve will be dilated under direct vision of the surgeon using a standard valve dilation balloon. The HLT valve will be loaded into a short version of the delivery catheter system and the catheter will be passed across the native valve.Measurements will be taken of the device relative to the anatomic structures of the heart. Once complete, the implant is removed from the native valve and the surgical valve replacement procedure is completed.<br>* Other names: AVR (aortic valve replacement);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| geometrical evaluation of HLT pliability to patient's native aortic valve |  | during surgery procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve stenosis, Heart surgery, Endovascular techniques