Aortic Valve StenosisAvalusNCT05572710
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Universitaire Ziekenhuizen KU Leuven at 19 sites in 8 countries.
Trial summary
This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- How many people
- 1,000 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 10 Jun 2020to 31 Dec 2025
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real world population indicated for aortic valve replacement
Who may be able to join
- Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis
- Age >= 18 years
- Patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide informed consent for participation in the clinical registry.
Who cannot join
- Patient requires salvage surgery (according to EuroSCORE II definitions: "patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia")
- Not been able to provide informed consent
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Italy6 sites, 6 recruiting
- Recruiting
Osp. S.Orsola Malpighi
Bologna
D. Pacini
- Recruiting
Fondazione Poliambulanza
Brescia
G. Troise
- Recruiting
Villa Maria Cecilia
Cotignola
Alberto Giovanni Tripodi
- Recruiting
Policlinico San Donato S.P.A
Milan
A. Canziani
- Recruiting
European Hospital
Roma
R. De Paulis
- Recruiting
A. Sanitaria O. Ordine Mauriziano
Torino
P. Centofanti
Belgium5 sites, 5 recruiting
- Recruiting
UCL St Luc
Brussels
Laurent de Kerckhove
- Recruiting
ZOL
Genk
Chris Van Kerrebroeck
- Recruiting
AZ Maria Middelares
Ghent
Koen Cathenis
- Recruiting
UZ Gent
Ghent
Katrien Francois
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Bart Meuris, +3216344260, Bart.meuris@uzleuven.be
Tom Verbelen, +3116344260, tom.verbelen@uzleuven.be
Germany2 sites, 2 recruiting
- Recruiting
Schüchtermann-Klinik
Bad Rothenfelde
Nicolas Doll
- Recruiting
Universität Herzzentrum
Hamburg
Hermann Reichenspurner
Spain2 sites, 2 recruiting
- Recruiting
Hospital Rambla
Santa Cruz de Tenerife
Rafael Llorens
- Recruiting
Hospital Clinico De Valladolid
Valladolid
Juan Bustamante
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio
Pekka Jaakkola
Netherlands1 site, 1 recruiting
- Recruiting
UMC Maastricht
Maastricht
Roberto Lorusso
About this study
This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.
Read the detailed description
The study is a prospective, observational, single-arm, multi-center registry. The patients must undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.
The goal of this project is to evaluate the real world results of aortic valve replacement with the Avalus valve. This will result in clinical and hemodynamic knowledge of this particular valve. The investigators are aiming for 1000 patient inclusions distributed over 40 sites across Europe and potentially also involving Canada.
Intentionally, we kept the inclusion criteria as wide as possible in order to obtain a real-world experience with and performance of the bioprosthesis. Patients younger than 18 years and salvage procedures are the only exclusion criteria from the registry. Outcome is evaluated in accordance with the VARC-2 criteria up to 1-year postoperatively.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality and disabling stroke
Composite of all-cause mortality and disabling stroke
Measured: 1 year
Secondary outcomes (1)
VARC-2
Mortality, stroke, bleeding complications, major vascular complications, new pacemaker implantation, prostethic valve function, composit endpoints
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start10 Jun 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572710
- Sponsor's protocol ID
- S63824
- Acronym
- Avalus
- Status last verified
- Jun 2024
- First submitted
- 5 Oct 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population
- ClinicalTrials.gov ID
- NCT05572710
- Acronym / sponsor ID
- Avalus / S63824
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Oct 2022 (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.
This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.
Detailed description
The study is a prospective, observational, single-arm, multi-center registry. The patients must undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.
The goal of this project is to evaluate the real world results of aortic valve replacement with the Avalus valve. This will result in clinical and hemodynamic knowledge of this particular valve. The investigators are aiming for 1000 patient inclusions distributed over 40 sites across Europe and potentially also involving Canada.
Intentionally, we kept the inclusion criteria as wide as possible in order to obtain a real-world experience with and performance of the bioprosthesis. Patients younger than 18 years and salvage procedures are the only exclusion criteria from the registry. Outcome is evaluated in accordance with the VARC-2 criteria up to 1-year postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real world population indicated for aortic valve replacement
Key inclusion criteria (3 listed)
- Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis
- Age >= 18 years
- Patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide informed consent for participation in the clinical registry.
Key exclusion criteria (2 listed)
- Patient requires salvage surgery (according to EuroSCORE II definitions: "patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia")
- Not been able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of all-cause mortality and disabling stroke
Time frame: 1 year
Composite of all-cause mortality and disabling stroke
1 secondary outcome
VARC-2
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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.
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Aortic Valve Insufficiency, run by Universitaire Ziekenhuizen KU Leuven at 19 sites in 8 countries.
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 2 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 1 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 19 sites in Italy, Belgium, Germany, Spain, Denmark and 3 more countries. 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 Bart Meuris (+32 16 344260, bart.meuris@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality and disabling stroke (time frame: 1 year). 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 1 Jul 2024.