Aortic Valve ReplacementNCT01522352
Comparison Between Three Types of Stented Pericardial Aortic Valves
A study testing Aortic valve replacement by bioprosthesis in people with Aortic Valve Replacement, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- Aortic valve replacement by bioprosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 2013
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 85 years who need aortic valve replacement (no endocarditis) With Bioprosthesis, with or without myocardial revascularization, with or without tricuspid valve repair surgery
Who cannot join
- no endocarditis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves
This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.
Read the detailed description
According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.
Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.
Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.
- Conditions
- Aortic Valve Replacement
- Being tested
- Aortic valve replacement by bioprosthesis
- Keywords
- Bioprosthesis,, aortic valve replacement, Magna Ease, Mitroflow, Trifecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacement by bioprosthesisProcedure or surgery
Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)
| Study group | Role | What they receive |
|---|---|---|
| pericardial aortic valves | Experimental | Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences) Receives: Procedure: Aortic valve replacement by bioprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of postoperative trans-valvular mean gradient by echocardiography
Measured: after 6 months
Secondary outcomes (5)
Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size
Measured: at six months
Comparison between the aortic annulus measurement and the implanted bioprosthesis size
Measured: at six months
Surgical outcome at hospital
Measured: at 6 months.
Postoperative trans-valvular mean gradient by echocardiography
Measured: at six months.
Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces
Measured: at six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences, Abbott Medical Devices, Sorin group, Italy, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Kasra AZARNOUSH, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522352
- Sponsor's protocol ID
- CHU-0109
- Status last verified
- Sep 2013
- First submitted
- 20 Dec 2011
- Last updated
- 4 Sep 2013
- Results posted
- No
Publications
Azarnoush K, Pereira B, Duale C, Dorigo E, Farhat M, Innorta A, Dauphin N, Geoffroy E, Chabrot P, Camilleri L. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial. Trials. 2013 Dec 3;14:413. doi: 10.1186/1745-6215-14-413.
PubMed 24299218
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves
- ClinicalTrials.gov ID
- NCT01522352
- Acronym / sponsor ID
- CHU-0109
- Conditions
- Aortic Valve Replacement
- Keywords
- Bioprosthesis,, aortic valve replacement, Magna Ease, Mitroflow, Trifecta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Edwards Lifesciences, Abbott Medical Devices, Sorin group, Italy, Ministry of Health, France
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 31 Jan 2012 (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.
This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.
Detailed description
According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.
Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.
Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.
Study design
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pericardial aortic valves | Experimental | Procedure: Aortic valve replacement by bioprosthesisComparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 18 and 85 years who need aortic valve replacement (no endocarditis) With Bioprosthesis, with or without myocardial revascularization, with or without tricuspid valve repair surgery
Key exclusion criteria (1 listed)
- no endocarditis
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 |
|---|---|---|
| Aortic valve replacement by bioprosthesisComparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences) | Procedure or surgery | pericardial aortic valves |
Primary outcome
measurement of postoperative trans-valvular mean gradient by echocardiography
Time frame: after 6 months
5 secondary outcomes
Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size
Time frame: at six months
Comparison between the aortic annulus measurement and the implanted bioprosthesis size
Time frame: at six months
Surgical outcome at hospital
Time frame: at 6 months.
Postoperative trans-valvular mean gradient by echocardiography
Time frame: at six months.
Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces
Time frame: at six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Derived from this study: PubMed 24299218Azarnoush K, Pereira B, Duale C, Dorigo E, Farhat M, Innorta A, Dauphin N, Geoffroy E, Chabrot P, Camilleri L. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial. Trials. 2013 Dec 3;14:413. doi: 10.1186/1745-6215-14-413.
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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.
Kasra AZARNOUSH, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic valve replacement by bioprosthesis in people with Aortic Valve Replacement, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 1 inclusion and 1 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 4 Sep 2013. 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 France. 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 Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of postoperative trans-valvular mean gradient by echocardiography (time frame: after 6 months). 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 NCT01522352, which also lists 1 linked publication.
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 4 Sep 2013; AzTrials last refreshed its copy on 6 Nov 2026.