Brief Title
Heart Leaflet Technologies Valve Study
Official Title
Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve
Brief Summary
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
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.
Study Type
Interventional
Primary Outcome
geometrical evaluation of HLT pliability to patient's native aortic valve
Condition
Aortic Valve Stenosis
Intervention
surgical replacement of the aortic stenotic valve
Study Arms / Comparison Groups
1
Description: Patients undergoing surgical aortic valve replacement on cardiopulmonary bypass.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
7
Start Date
November 2007
Completion Date
December 2008
Primary Completion Date
December 2008
Eligibility Criteria
Inclusion Criteria:
1. Patients undergoing aortic valve replacement for aortic valve stenosis with a
preoperative valve area < 0.9 cm2.
2. A preoperative echocardiogram where the aortic annulus diameter can be measured and is
between 19 and 25 mm internal diameter.
3. Age 75 to 80 years
Exclusion Criteria:
1. Emergency valve surgery
2. Significant ascending aortic disease (atheroma, extensive calcification, dissection)
as assessed by the operating surgeon
3. Ostial coronary obstruction > 25% diameter stenosis
Gender
All
Ages
75 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Paolo Biglioli, MD, +39/02/5800, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00710775
Organization ID
R78- CCM S80/507
Study Sponsor
Centro Cardiologico Monzino
Study Sponsor
Paolo Biglioli, MD, Principal Investigator, Centro Cardiologico Monzino-University of Milan
Verification Date
May 2008