Heart Leaflet Technologies Valve Study (HLT)
Recruitment status was: Recruiting
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.
|Aortic Valve Stenosis Endovascular Aortic Valve Replacement||Procedure: surgical replacement of the aortic stenotic valve|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve|
- geometrical evaluation of HLT pliability to patient's native aortic valve [ Time Frame: during surgery procedure ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||December 2008|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Patients undergoing surgical aortic valve replacement on cardiopulmonary bypass.
Procedure: surgical replacement of the aortic stenotic valve
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.
Other Name: AVR (aortic valve replacement)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710775
|Contact: Paolo Biglioli, MD||+39/02/5800 ext firstname.lastname@example.org|
|Contact: Luca Dainese, MD||+39/02/5800 ext email@example.com|
|Centro Cardiologico Monzino- University of Milan, Italy||Recruiting|
|Milan, Italy, 20138|
|Contact: Paolo Biglioli, MD +39/02/5800 ext 2373 firstname.lastname@example.org|
|Contact: Luca Dainese, MD +39/02/5800 ext 2563 email@example.com|
|Sub-Investigator: Melissa Fusari, MD|
|Principal Investigator:||Paolo Biglioli, MD||Centro Cardiologico Monzino-University of Milan|