- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710775
Heart Leaflet Technologies Valve Study (HLT)
Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve
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.
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paolo Biglioli, MD
- Phone Number: 2373 +39/02/5800
- Email: paolo.biglioli@ccfm.it
Study Contact Backup
- Name: Luca Dainese, MD
- Phone Number: 2563 +39/02/5800
- Email: luca.dainese@ccfm.it
Study Locations
-
-
-
Milan, Italy, 20138
- Recruiting
- Centro Cardiologico Monzino- University of Milan, Italy
-
Contact:
- Paolo Biglioli, MD
- Phone Number: 2373 +39/02/5800
- Email: paolo.biglioli@ccfm.it
-
Contact:
- Luca Dainese, MD
- Phone Number: 2563 +39/02/5800
- Email: luca.dainese@ccfm.it
-
Sub-Investigator:
- Melissa Fusari, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Patients undergoing surgical aortic valve replacement on cardiopulmonary bypass.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
geometrical evaluation of HLT pliability to patient's native aortic valve
Time Frame: during surgery procedure
|
during surgery procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paolo Biglioli, MD, Centro Cardiologico Monzino-University of Milan
Publications and helpful links
General Publications
- Ghanbari H, Kidane AG, Burriesci G, Bonhoeffer P, Seifalian AM. Percutaneous heart valve replacement: an update. Trends Cardiovasc Med. 2008 May;18(4):117-25. doi: 10.1016/j.tcm.2008.02.002.
- Webb JG. Percutaneous aortic valve replacement. Curr Cardiol Rep. 2008 Mar;10(2):104-9. doi: 10.1007/s11886-008-0019-z.
- Rosengart TK, Feldman T, Borger MA, Vassiliades TA Jr, Gillinov AM, Hoercher KJ, Vahanian A, Bonow RO, O'Neill W; American Heart Association Council on Cardiovascular Surgery and Anesthesia; American Heart Association Council on Clinical Cardiology; Functional Genomics and Translational Biology Interdisciplinary Working Group; Quality of Care and Outcomes Research Interdisciplinary Working Group. Percutaneous and minimally invasive valve procedures: a scientific statement from the American Heart Association Council on Cardiovascular Surgery and Anesthesia, Council on Clinical Cardiology, Functional Genomics and Translational Biology Interdisciplinary Working Group, and Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2008 Apr 1;117(13):1750-67. doi: 10.1161/CIRCULATIONAHA.107.188525. Epub 2008 Mar 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R78- CCM S80/507
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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