Heart Leaflet Technologies Valve Study (HLT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Centro Cardiologico Monzino.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00710775
First received: June 27, 2008
Last updated: October 9, 2009
Last verified: May 2008
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve

Resource links provided by NLM:


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.
Other Name: AVR (aortic valve replacement)

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Centro Cardiologico Monzino:
Aortic valve stenosis
Heart surgery
Endovascular techniques

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 01, 2014