Heart Leaflet Technologies Valve Study - Full Text View

Sponsor:	Centro Cardiologico Monzino
Information provided by:	Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:	NCT00710775

Purpose

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.

Condition	Intervention
Aortic Valve Stenosis Endovascular Aortic Valve Replacement	Procedure: surgical replacement of the aortic stenotic valve

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Official Title:	Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:

geometrical evaluation of HLT pliability to patient's native aortic valve [ Time Frame: during surgery procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	7
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)

Arms	Assigned Interventions
1 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.

Arms

Assigned Interventions

1

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.

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.

Eligibility

Ages Eligible for Study:	75 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710775

Contacts

Contact: Paolo Biglioli, MD	+39/02/5800 ext 2373	paolo.biglioli@ccfm.it
Contact: Luca Dainese, MD	+39/02/5800 ext 2563	luca.dainese@ccfm.it

Locations

Italy
Centro Cardiologico Monzino- University of Milan, Italy	Recruiting
Milan, Italy, 20138
Contact: Paolo Biglioli, MD +39/02/5800 ext 2373 paolo.biglioli@ccfm.it
Contact: Luca Dainese, MD +39/02/5800 ext 2563 luca.dainese@ccfm.it
Sub-Investigator: Melissa Fusari, MD

Sponsors and Collaborators

Centro Cardiologico Monzino

Investigators

Principal Investigator:

Paolo Biglioli, MD

Centro Cardiologico Monzino-University of Milan

More Information

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.

Webb JG. Percutaneous aortic valve replacement. Curr Cardiol Rep. 2008 Mar;10(2):104-9. Review.

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. Epub 2008 Mar 10. Review.

Responsible Party:	Centro Cardiologico Monzino-University of Milan ( Paolo Biglioli, Prof. )
Study ID Numbers:	R78- CCM S80/507
Study First Received:	June 27, 2008
Last Updated:	October 9, 2009
ClinicalTrials.gov Identifier:	NCT00710775 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Centro Cardiologico Monzino:

Aortic valve stenosis
Heart surgery
Endovascular techniques

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases
Aortic Valve Stenosis
Ventricular Outflow Obstruction
Heart Valve Diseases

ClinicalTrials.gov processed this record on February 08, 2010