Aortic Valve StenosisINDURENCT03666741
Inspiris Resilia Durability Registry
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 21 sites in 9 countries.
Trial summary
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- AVR with or without CABG
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 21 sitesin 9 countries
- Study dates
- 26 Apr 2019to Jul 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients under the age of 60 with an indication for surgical AVR who will receive an Edwards INSPIRIS RESILIA aortic valve prosthesis.
Who may be able to join
- Age 18 to 60 years inclusive
- Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation
- Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery
- Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up
- Subject provides written informed consent prior to the procedure
Who cannot join
- Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
- Previous aortic valve replacement
- Valve implantation is not possible in accordance with the device IFU
- Subject has a life expectancy ≤ 12 months for any reason
- Intraoperative Exclusion criteria:
- 1. Valve implantation is not possible in accordance with the device IFU
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
France4 sites
Hopital de la Timone
Marseille, 13005
L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes)
Nantes, 44100
Centre Hospitalier Universitaire (CHU) de Rennes
Rennes, 35033
CHRU - Hospital Trousseau
Tours
Italy4 sites
University Hospital Careggi
Florence, 50139
Centro Cardiologico Monzino
Milan, 20138
European Hospital Rome
Roma
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, 84131
Austria3 sites
University Clinics St. Pölten
Sankt Pölten, 3100
Heart Center Hietzing
Vienna, 1080
Medical University Vienna
Vienna, 1090
United Kingdom3 sites
NHS Lothian
Edinburgh, EH1 3EG
Glenfield Hospital
Glenfield, LE3 9QP
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Canada2 sites
Institut de Cardiologie de Montréal, Université de Montréal
Montreal, H1T 1C8
Laval University
Québec, G1v 0A6
Germany2 sites
UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Heart Center Leipzig
Leipzig
About this study
Official title: Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.
Read the detailed description
The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.
The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5.
The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from COMMENCE Trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to VARC-2) is around 0.915. The following table illustrates 95% CIs at different levels of risk:
Sample Size Observed freedom from event 95%CI 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250
20% of registry sites will be monitored with 100% source data verification
- Conditions
- Aortic Valve Stenosis
- Being tested
- AVR with or without CABG
- Keywords
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Surgical valve
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVR with or without CABGDevice
Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-related valve safety
Composite endpoint according to VARC-2 depicted as freedom from event:
- SVD (structural valve deterioration)
- Valve-related dysfunction
- Requirement of repeat procedure
- Prosthetic valve endocarditis
- Prosthetic valve thrombosis
- Thromboembolic events (e.g. stroke)
- Valve-related VARC bleeding
Measured: Year 1
Freedom from severe SVD (structural valve deterioration)
Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start26 Apr 2019
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Peter Bramlage, Professor, Study director, CEO IPPMedRuggero dePaulis, Professor, Principal investigator, European Hospital Rome, ItalyBart Meuris, Professor, Principal investigator, UZ Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666741
- Sponsor's protocol ID
- HVT-R18-IND
- Acronym
- INDURE
- Status last verified
- Jun 2025
- First submitted
- 10 Sep 2018
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015 Jan;149(1):340-5. doi: 10.1016/j.jtcvs.2014.09.062. Epub 2014 Sep 28.
PubMed 25439467Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.
PubMed 28605428Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EuroIntervention. 2012 Nov 22;8(7):782-95. doi: 10.4244/EIJV8I7A121.
PubMed 23022744Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG, Treede H, Sarano ME, Feldman T, Wijeysundera HC, Topilsky Y, Aupart M, Reardon MJ, Mackensen GB, Szeto WY, Kornowski R, Gammie JS, Yoganathan AP, Arbel Y, Borger MA, Simonato M, Reisman M, Makkar RR, Abizaid A, McCabe JM, Dahle G, Aldea GS, Leipsic J, Pibarot P, Moat NE, Mack MJ, Kappetein AP, Leon MB; VIVID (Valve in Valve International Data) Investigators. Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves. Circulation. 2018 Jan 23;137(4):388-399. doi: 10.1161/CIRCULATIONAHA.117.030729.
PubMed 29358344Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244. No abstract available.
PubMed 28874031De Paulis R, Bakhtiary F, Ahmad AE, Andreas M, Autschbach R, Benedikt P, Binder K, Bonaros N, Borger M, Bourguignon T, Canovas S, Coscioni E, Dagenais F, Demers P, Dewald O, Doll N, Feyrer R, Geissler HJ, Grabenwoger M, Grunenfelder J, Kueri S, Lam KY, Langanay T, Laufer G, Van Leeuwen W, Karimli S, Liebold A, Mariscalco G, Massoudy P, Mehdiani A, Pessotto R, Pollari F, Poling J, Polvani G, Ricci A, Roussel JC, Salamate S, Siepe M, Stefano P, Strauch J, Theron A, Votsch A, Weber A, Wendler O, Thielmann M, Eden M, Botta B, Bramlage P, Meuris B, Zierer A. Gender-based outcomes following surgical aortic valve replacement: a multicentre propensity score matching analysisdagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf099. doi: 10.1093/ejcts/ezaf099.
PubMed 40608978Meuris B, Roussel JC, Borger MA, Siepe M, Stefano P, Laufer G, Langanay T, Theron A, Grabenwoger M, Binder K, Demers P, Pessotto R, van Leeuwen W, Bourguignon T, Canovas S, Mariscalco G, Coscioni E, Dagenais F, Wendler O, Polvani G, Eden M, Botta B, Bramlage P, De Paulis R. Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry. Interdiscip Cardiovasc Thorac Surg. 2023 Oct 4;37(4):ivad115. doi: 10.1093/icvts/ivad115.
PubMed 37462612Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwoger M, Laufer G, Binder K, Polvani G, Stefano P, Coscioni E, van Leeuwen W, Demers P, Dagenais F, Canovas S, Theron A, Langanay T, Roussel JC, Wendler O, Mariscalco G, Pessotto R, Botta B, Bramlage P, de Paulis R. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020 May 27;15(1):119. doi: 10.1186/s13019-020-01155-6.
PubMed 32460798
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03666741
- Acronym / sponsor ID
- INDURE / HVT-R18-IND
- Conditions
- Aortic Valve Stenosis
- Keywords
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Surgical valve
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Sep 2018 (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.
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.
Detailed description
The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.
The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5.
The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from COMMENCE Trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to VARC-2) is around 0.915. The following table illustrates 95% CIs at different levels of risk:
Sample Size Observed freedom from event 95%CI 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250
20% of registry sites will be monitored with 100% source data verification
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients under the age of 60 with an indication for surgical AVR who will receive an Edwards INSPIRIS RESILIA aortic valve prosthesis.
Key inclusion criteria (5 listed)
- Age 18 to 60 years inclusive
- Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation
- Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery
- Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up
- Subject provides written informed consent prior to the procedure
Key exclusion criteria (6 listed)
- Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
- Previous aortic valve replacement
- Valve implantation is not possible in accordance with the device IFU
- Subject has a life expectancy ≤ 12 months for any reason
- 1. Valve implantation is not possible in accordance with the device IFU
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 |
|---|---|---|
| AVR with or without CABGSurgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™ | Device | – |
Primary outcome
Time-related valve safety
Time frame: Year 1
Composite endpoint according to VARC-2 depicted as freedom from event: * SVD (structural valve deterioration) * Valve-related dysfunction * Requirement of repeat procedure * Prosthetic valve endocarditis * Prosthetic valve thrombosis * Thromboembolic events (e.g. stroke) * Valve-related VARC bleeding
Freedom from severe SVD (structural valve deterioration)
Time frame: Year 5
Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 25439467Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015 Jan;149(1):340-5. doi: 10.1016/j.jtcvs.2014.09.062. Epub 2014 Sep 28.
- Background: PubMed 28605428Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.
- Background: PubMed 23022744Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EuroIntervention. 2012 Nov 22;8(7):782-95. doi: 10.4244/EIJV8I7A121.
- Background: PubMed 29358344Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG, Treede H, Sarano ME, Feldman T, Wijeysundera HC, Topilsky Y, Aupart M, Reardon MJ, Mackensen GB, Szeto WY, Kornowski R, Gammie JS, Yoganathan AP, Arbel Y, Borger MA, Simonato M, Reisman M, Makkar RR, Abizaid A, McCabe JM, Dahle G, Aldea GS, Leipsic J, Pibarot P, Moat NE, Mack MJ, Kappetein AP, Leon MB; VIVID (Valve in Valve International Data) Investigators. Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves. Circulation. 2018 Jan 23;137(4):388-399. doi: 10.1161/CIRCULATIONAHA.117.030729.
- Background: PubMed 28874031Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244. No abstract available.
- Derived from this study: PubMed 40608978De Paulis R, Bakhtiary F, Ahmad AE, Andreas M, Autschbach R, Benedikt P, Binder K, Bonaros N, Borger M, Bourguignon T, Canovas S, Coscioni E, Dagenais F, Demers P, Dewald O, Doll N, Feyrer R, Geissler HJ, Grabenwoger M, Grunenfelder J, Kueri S, Lam KY, Langanay T, Laufer G, Van Leeuwen W, Karimli S, Liebold A, Mariscalco G, Massoudy P, Mehdiani A, Pessotto R, Pollari F, Poling J, Polvani G, Ricci A, Roussel JC, Salamate S, Siepe M, Stefano P, Strauch J, Theron A, Votsch A, Weber A, Wendler O, Thielmann M, Eden M, Botta B, Bramlage P, Meuris B, Zierer A. Gender-based outcomes following surgical aortic valve replacement: a multicentre propensity score matching analysisdagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf099. doi: 10.1093/ejcts/ezaf099.
- Derived from this study: PubMed 37462612Meuris B, Roussel JC, Borger MA, Siepe M, Stefano P, Laufer G, Langanay T, Theron A, Grabenwoger M, Binder K, Demers P, Pessotto R, van Leeuwen W, Bourguignon T, Canovas S, Mariscalco G, Coscioni E, Dagenais F, Wendler O, Polvani G, Eden M, Botta B, Bramlage P, De Paulis R. Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry. Interdiscip Cardiovasc Thorac Surg. 2023 Oct 4;37(4):ivad115. doi: 10.1093/icvts/ivad115.
- Derived from this study: PubMed 32460798Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwoger M, Laufer G, Binder K, Polvani G, Stefano P, Coscioni E, van Leeuwen W, Demers P, Dagenais F, Canovas S, Theron A, Langanay T, Roussel JC, Wendler O, Mariscalco G, Pessotto R, Botta B, Bramlage P, de Paulis R. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020 May 27;15(1):119. doi: 10.1186/s13019-020-01155-6.
- 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.
Peter Bramlage, Professor study director
CEO IPPMed
Ruggero dePaulis, Professor principal investigator
European Hospital Rome, Italy
Bart Meuris, Professor principal investigator
UZ Leuven, Belgium
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Institut für Pharmakologie und Präventive Medizin at 21 sites in 9 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France, Italy, Austria, United Kingdom, Canada and 4 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?
This study is still under way. Results are not available in the source record yet.
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?
Time-related valve safety (time frame: Year 1). The study lists 2 primary outcomes in all. 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 NCT03666741, which also lists 8 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 15 Jun 2025.