Aortic Valve StenosisHLTNCT00710775
Heart Leaflet Technologies Valve Study
A study testing surgical replacement of the aortic stenotic valve in people with Aortic Valve Stenosis and Endovascular Aortic Valve Replacement, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 80 years
- Conditions the study is for
- Aortic Valve Stenosis, Endovascular Aortic Valve Replacement
- What is being tested?
- surgical replacement of the aortic stenotic valve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Emergency valve surgery
- Significant ascending aortic disease (atheroma, extensive calcification, dissection) as assessed by the operating surgeon
- Ostial coronary obstruction > 25% diameter stenosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino- University of Milan, Italy
Milan, 20138
Paolo Biglioli, MD, +39/02/5800 ext. 2373, paolo.biglioli@ccfm.it
Luca Dainese, MD, +39/02/5800 ext. 2563, luca.dainese@ccfm.it
About this study
Official title: 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.
Read the 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.
- Being tested
- surgical replacement of the aortic stenotic valve
- Keywords
- Aortic valve stenosis, Heart surgery, Endovascular techniques
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical replacement of the aortic stenotic valveProcedure or surgery
Also called AVR (aortic valve replacement)
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients undergoing surgical aortic valve replacement on cardiopulmonary bypass. Receives: Procedure: surgical replacement of the aortic stenotic valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
geometrical evaluation of HLT pliability to patient's native aortic valve
Measured: during surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Investigators
- Paolo Biglioli, MD, Principal investigator, Centro Cardiologico Monzino-University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710775
- Sponsor's protocol ID
- R78- CCM S80/507
- Acronym
- HLT
- Status last verified
- May 2008
- First submitted
- 27 Jun 2008
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18555184Webb JG. Percutaneous aortic valve replacement. Curr Cardiol Rep. 2008 Mar;10(2):104-9. doi: 10.1007/s11886-008-0019-z.
PubMed 18417010Rosengart 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.
PubMed 18332270
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Intra-operative Placement of HLT Percutaneous Aortic Valve
- ClinicalTrials.gov ID
- NCT00710775
- Acronym / sponsor ID
- HLT / R78- CCM S80/507
- Keywords
- Aortic valve stenosis, Heart surgery, Endovascular techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: surgical replacement of the aortic stenotic valvePatients undergoing surgical aortic valve replacement on cardiopulmonary bypass. |
Who may qualify
- Ages
- 75 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Emergency valve surgery
- Significant ascending aortic disease (atheroma, extensive calcification, dissection) as assessed by the operating surgeon
- Ostial coronary obstruction > 25% diameter stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical replacement of the aortic stenotic valveAlso: AVR (aortic valve replacement)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. | Procedure or surgery | 1 |
Primary outcome
geometrical evaluation of HLT pliability to patient's native aortic valve
Time frame: during surgery procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
- Background: PubMed 18555184Ghanbari 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.
- Background: PubMed 18417010Webb JG. Percutaneous aortic valve replacement. Curr Cardiol Rep. 2008 Mar;10(2):104-9. doi: 10.1007/s11886-008-0019-z.
- Background: PubMed 18332270Rosengart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Biglioli, MD principal investigator
Centro Cardiologico Monzino-University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical replacement of the aortic stenotic valve in people with Aortic Valve Stenosis and Endovascular Aortic Valve Replacement, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Biglioli, MD (+39/02/5800 ext. 2373, paolo.biglioli@ccfm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
geometrical evaluation of HLT pliability to patient's native aortic valve (time frame: during surgery procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00710775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2009.