Aortic Valve DiseaseNCT04359030
Freestyle-Perimount Calcification Comparison
An observational study of Aortic Valve Disease and Valve Heart Disease, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Aortic Valve Disease, Valve Heart Disease
- What is being tested?
- Multislice CT scanning for aortic wall calcification and Transthoracic stress echocardiography
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2021to 1 Oct 2022
- Phase
- Observational
- 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 Up to 60 years
- All sexes
- Child, Adult
Study population: Patients operated for aortic valve stenosis at least three years earlier undergoing a valve replacement with Freestyle (FS) or Perimount (PM) bioprosthesis under the age of 60 years.
Who may be able to join
- Provision of signed and dated informed consent form
- Patients treated with FS or PM
- Age less than 60 at the moment of the implant
Who cannot join
- Kidney failure or contrast allergy
- Previous endocarditis and aortic dissection
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Calcium Score Measurement After Freestyle Full Root Replacement in Young Adults
The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.
Read the detailed description
A recent update of the American Hear Association and American College of Cardiology Guidelines for the Management of Patients With Valvular Heart Disease1 recommended that for patients between 50 and 70 years of age, it is reasonable to the choice of either a mechanical or bioprosthetic valve; the threshold for biological valves continues to decrease and more younger adults will receive this kind of prosthesis. However the best biological option for these patients is still a matter of debate. Stented bio-prosthesis is the most common choice. However, the predicted 15-year risk of needing reoperation because of structural deterioration is 22% for patients 50 years of age2.
In the late 80's stentless valve as the Medtronic Freestyle (FS) has been introduced with the hope that it may provide physiological flow in the aortic root, sinuses, and coronary orifices and a low risk of thromboembolism. Several randomized study and meta-analysis demonstrated improved hemodynamic, a larger orifice area and a midterm survival advantage of stentless aortic valve compared to stented aortic valve replacement3, 4. The FS valve is believed to provide greater durability and superior hemodynamic performance due to the low mechanical stress on the leaflet tissues. The failure mode of the FS is thought to be mostly calcification of the aorta wall and cusp tears because collagen degradation5. This phenomenon is inflammation mediated process.
Aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.
Between 2007 and 2017, among patients younger than 60 years of age, 51 patients underwent a full root replacement with a FS and 49 received a Perimount Magna Ease prosthesis. Those patients will undergo a 3D CT scan. The group of the patient with PM will be matched in function of age and interval of follow-up with the FS group.
A transthoracic echocardiogram will be performed to check residual valve insufficiency and trans-valvular gradients. A cardiopulmonary exercise test ( with extraction of maximal oxygen consumption ) combined with a trans thoracic echocardiography (stress echocardiography) will be performed to evaluate the patients exercise capacity and its influence on the cardiac and valve function.
- Conditions
- Aortic Valve Disease, Valve Heart Disease
- Being tested
- Multislice CT scanning for aortic wall calcification, Transthoracic stress echocardiography
- Medical subject headings
- Aortic Valve Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multislice CT scanning for aortic wall calcificationDiagnostic test
Multislice CT scanning for aortic wall calcification
Transthoracic stress echocardiographyDiagnostic test
Transthoracic stress echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Freestyle group | Patients treated with a Freestyle aortic valve bioprosthesis Receives: Diagnostic Test: Multislice CT scanning for aortic wall calcification; Diagnostic Test: Transthoracic stress echocardiography | |
| Perimount group | Patients treated with a Perimount aortic valve bioprosthesis Receives: Diagnostic Test: Multislice CT scanning for aortic wall calcification; Diagnostic Test: Transthoracic stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of aortic leaflet Calcium-score in FS and PM valve
The Agatston score. The score is calculated using a weighted value assigned to the highest density of calcification in a given coronary artery. The density is measured in Hounsfield units (HU), and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater. The higher the score the more the calcification.
Measured: 3 years
Secondary outcomes (4)
Echocardiographic function of the aortic valve at rest and during exercise: transvalvular mean and peak gradient
Aortic valve mean and peak gradient: mmHg
Measured: 3 years
Echocardiographic function of the aortic valve at rest and during exercise: Valve regurgitation
Aortic valve regurgitation: vena contracta (mm)
Measured: 3 years
Exercise capacity: New York Heart Association class
New York Heart Association class from 1 to 4 with 1=no dyspnea during exercise till 4= dyspnea in rest;
Measured: 3 years
Exercise capacity: maximum oxygen consumption
max oxygen consumption measured in ml/kg*min
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Matteo Pettinari, Ziekenhuis Oost-Limburg
- Investigators
- Matteo Pettinari, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359030
- Sponsor's protocol ID
- ctu2020003
- Status last verified
- Jul 2024
- First submitted
- 17 Mar 2020
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Calcium Score Measurement After Freestyle Full Root Replacement in Young Adults
- ClinicalTrials.gov ID
- NCT04359030
- Acronym / sponsor ID
- ctu2020003
- Conditions
- Aortic Valve Disease, Valve Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 24 Apr 2020 (actual)
- 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 aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.
Detailed description
A recent update of the American Hear Association and American College of Cardiology Guidelines for the Management of Patients With Valvular Heart Disease1 recommended that for patients between 50 and 70 years of age, it is reasonable to the choice of either a mechanical or bioprosthetic valve; the threshold for biological valves continues to decrease and more younger adults will receive this kind of prosthesis. However the best biological option for these patients is still a matter of debate. Stented bio-prosthesis is the most common choice. However, the predicted 15-year risk of needing reoperation because of structural deterioration is 22% for patients 50 years of age2.
In the late 80's stentless valve as the Medtronic Freestyle (FS) has been introduced with the hope that it may provide physiological flow in the aortic root, sinuses, and coronary orifices and a low risk of thromboembolism. Several randomized study and meta-analysis demonstrated improved hemodynamic, a larger orifice area and a midterm survival advantage of stentless aortic valve compared to stented aortic valve replacement3, 4. The FS valve is believed to provide greater durability and superior hemodynamic performance due to the low mechanical stress on the leaflet tissues. The failure mode of the FS is thought to be mostly calcification of the aorta wall and cusp tears because collagen degradation5. This phenomenon is inflammation mediated process.
Aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.
Between 2007 and 2017, among patients younger than 60 years of age, 51 patients underwent a full root replacement with a FS and 49 received a Perimount Magna Ease prosthesis. Those patients will undergo a 3D CT scan. The group of the patient with PM will be matched in function of age and interval of follow-up with the FS group.
A transthoracic echocardiogram will be performed to check residual valve insufficiency and trans-valvular gradients. A cardiopulmonary exercise test ( with extraction of maximal oxygen consumption ) combined with a trans thoracic echocardiography (stress echocardiography) will be performed to evaluate the patients exercise capacity and its influence on the cardiac and valve function.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freestyle group | – | Diagnostic Test: Multislice CT scanning for aortic wall calcification, Diagnostic Test: Transthoracic stress echocardiographyPatients treated with a Freestyle aortic valve bioprosthesis |
| Perimount group | – | Diagnostic Test: Multislice CT scanning for aortic wall calcification, Diagnostic Test: Transthoracic stress echocardiographyPatients treated with a Perimount aortic valve bioprosthesis |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients operated for aortic valve stenosis at least three years earlier undergoing a valve replacement with Freestyle (FS) or Perimount (PM) bioprosthesis under the age of 60 years.
Key inclusion criteria (3 listed)
- Provision of signed and dated informed consent form
- Patients treated with FS or PM
- Age less than 60 at the moment of the implant
Key exclusion criteria (3 listed)
- Kidney failure or contrast allergy
- Previous endocarditis and aortic dissection
- Pregnancy or lactation
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 |
|---|---|---|
| Multislice CT scanning for aortic wall calcificationMultislice CT scanning for aortic wall calcification | Diagnostic test | Freestyle group, Perimount group |
| Transthoracic stress echocardiographyTransthoracic stress echocardiography | Diagnostic test | Freestyle group, Perimount group |
Primary outcome
Quantification of aortic leaflet Calcium-score in FS and PM valve
Time frame: 3 years
The Agatston score. The score is calculated using a weighted value assigned to the highest density of calcification in a given coronary artery. The density is measured in Hounsfield units (HU), and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater. The higher the score the more the calcification.
4 secondary outcomes
Echocardiographic function of the aortic valve at rest and during exercise: transvalvular mean and peak gradient
Time frame: 3 years
Echocardiographic function of the aortic valve at rest and during exercise: Valve regurgitation
Time frame: 3 years
Exercise capacity: New York Heart Association class
Time frame: 3 years
Exercise capacity: maximum oxygen consumption
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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.
Matteo Pettinari principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Valve Heart Disease, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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: finished, as of the sponsor's last update on 24 Jul 2024. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of aortic leaflet Calcium-score in FS and PM valve (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2024.