Aortic Valve DiseaseSURE-AVRNCT02679404
Sorin Universal REgistry on Aortic Valve Replacement
An observational study of Aortic Valve Disease and Aortic Stenosis, run by Corcym S.r.l at 52 sites in 17 countries.
Trial summary
Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide. The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Stenosis
- How many people
- 2,758 participants
- Where
- 52 sitesin 17 countries
- Study dates
- May 2015to Mar 2021
- 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: All patients having received a Sorin Group aortic valve device in accordance with the IFU can be included in the registry. Other than the indication and the contra-indications specified in each IFU, there are no specific inclusion and exclusion criteria since this registry has the aim to include all patients following "real life"/standard of care practices at participating centers. All patients must provide written or oral informed consent to participate in the registry following the local regulations.
Who may be able to join
- All patients must provide written or oral informed consent to participate in the registry depending on the local regulations.
- Patients having received a Sorin Group aortic valve device in accordance with the IFU
Who cannot join
None listed.
Trial locations and contacts
52 sites in 17 countries.
52 sites in 17 countries
Italy12 sites
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo
Alessandria
Policlinico S.Orsola-Malpighi
Bologna
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Città di Lecce Hospital
Lecce
Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
Massa, 54100
Centro Cardiologico Monzino
Milan
Istituto Clinico Sant'Ambrogio
Milan
Policlinico Paolo Giaccone
Palermo
IRCCS Policlinico San Donato
San Donato Milanese
Ospedale Ca' Foncello - Treviso
Treviso
Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
Trieste
Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine
Udine
France6 sites
CHU Bordeaux
Bordeaux
Clinique Saint Augustin
Bordeaux
CHU Clermont-Ferrand
Clermont-Ferrand
Clinique la Protestante
Lyon
CHU La Timone
Marseille
CHU Rennes
Rennes
United Kingdom6 sites
Blackpool Teaching Hospital
Blackpool
Royal Sussex County Hospital - Brighton
Brighton
Bristol Royal Infirmary
Bristol
Hammersmith Hospital
London
King's College Hospital
London
Royal Brompton
London
United States5 sites
Princeton Baptist Med Center
Birmingham, Alabama, 35211
Mount Carmel Hospital
Columbus, Ohio, 43213
River City Clinical Research
Jacksonville, Florida, 32207
Columbia University Hospital
New York, New York, 10032
Baylor Scott and White Research Institute
Plano, Texas, 75093
Spain4 sites
Hospital Juan Canalejo
A Coruña
Hospital Sant Pau
Barcelona
Hospital Reina Sofía
Córdoba
Hospital Clínico San Carlos
Madrid
Australia2 sites
Melbourne Private Hospital
Melbourne
Royal Melbourne Hospital
Melbourne
Czechia2 sites
Center of Cardiovascular Surgery and Transplantation Brno
Brno
IKEM - Prague
Prague
Germany2 sites
Universitätsklinikum Magdeburg
Magdeburg
Nuremberg Hospital
Nuremberg
Switzerland2 sites
University Hospital of Basel
Basel
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne
About this study
Multi-center, International, Prospective, Non comparative, Non randomized, Open label.
5,000 patients to be enrolled approximately worldwide.
Read more
The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.
Read the detailed description
SURE-AVR objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with the IFU to further evidence the safety and efficacy in a post-approval environment. All current and future Sorin Group aortic valve devices that have obtained CE-mark or other local regulatory and/or commercial approvals may be included in the registry. During the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. This registry allows extensions for the inclusion of new products.
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations.
The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive.
The registry is an open-ended project:
- Inclusions phase: open-ended
- Follow-up phase: annually throughout 5 years (7 and 10 years are optional).
The study shall be completed after the 10-year follow-up of the last patient.
- Conditions
- Aortic Valve Disease, Aortic Stenosis
- Keywords
- Biological aortic valves, Mechanical aortic valves, Aortic conduits, Sutureless Aortic Valve
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of valve related major adverse events (MAEs)
To evaluate the composite rate of site reported valve related MAE defined as death, stroke and/or re-intervention (involving surgery or any other invasive therapy) at 5 years follow-up.
Measured: At 5 years follow-up
Secondary outcomes (7)
Procedural timings
Cross clamp time, intensive care unit and total length of hospital stay.
Measured: Intra-operative and at 30 days (average)
Clinical success
The clinical success defined as a successful valve implantation without MAE at hospital discharge.
Measured: 30 days (average)
Improvement of clinical status
The improvement of clinical status defined as an improvement of at least one scale of the New York Heart Association (NYHA) classification between pre-procedure and annually throughout the duration of the registry.
Measured: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Echocardiographic evaluation
Performance of the device in terms of hemodynamic behavior - Effective Orifice Area (cm²), Ejection Fraction (%),Mean Aortic Gradient (mmHg), Peak Aortic Gradient (mmHg), LV mass (g) - throughout the duration of the registry.
Measured: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
MAE during the duration of the registry
All site reported MAE rates during the duration of the registry.
Measured: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Composite rate of valve related MAE
The composite rate of site reported valve-related MAE annually through a 4-year follow-up, and 7 and 10-year follow-up in selected centers only.
Measured: 4-year, and 7 and 10-year follow-up in selected centers only
Valve-related Serious Adverse Event (SAE)
Other site reported valve-related SAE such as, but not limited to, bleeding, thromboembolism, valve thrombosis, endocarditis, non structural dysfunction, structural valve deterioration annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Measured: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startMay 2015
- Primary completionMar 2021
- Study completionMar 2021
Why it stopped: Less data return than expected. The new Medical Device Regulation (MDR) implementation prompted the Sponsor to set up a broader scope post-market registry for all Corcym cardiovascular products (MANTRA).
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,758 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Gaggianesi, Study director, Corcym S.r.l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679404
- Sponsor's protocol ID
- APR001
- Acronym
- SURE-AVR
- Status last verified
- Mar 2024
- First submitted
- 27 Jan 2016
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorin Universal REgistry on Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT02679404
- Acronym / sponsor ID
- SURE-AVR / APR001
- Conditions
- Aortic Valve Disease, Aortic Stenosis
- Keywords
- Biological aortic valves, Mechanical aortic valves, Aortic conduits, Sutureless Aortic Valve
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Less data return than expected. The new Medical Device Regulation (MDR) implementation prompted the Sponsor to set up a broader scope post-market registry for all Corcym cardiovascular products (MANTRA).
- Enrolment
- 2,758 participants (actual)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 10 Feb 2016 (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.
Multi-center, International, Prospective, Non comparative, Non randomized, Open label.
5,000 patients to be enrolled approximately worldwide.
The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.
Detailed description
SURE-AVR objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with the IFU to further evidence the safety and efficacy in a post-approval environment. All current and future Sorin Group aortic valve devices that have obtained CE-mark or other local regulatory and/or commercial approvals may be included in the registry. During the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. This registry allows extensions for the inclusion of new products.
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations.
The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive.
The registry is an open-ended project:
- Inclusions phase: open-ended
- Follow-up phase: annually throughout 5 years (7 and 10 years are optional).
The study shall be completed after the 10-year follow-up of the last patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients having received a Sorin Group aortic valve device in accordance with the IFU can be included in the registry. Other than the indication and the contra-indications specified in each IFU, there are no specific inclusion and exclusion criteria since this registry has the aim to include all patients following "real life"/standard of care practices at participating centers. All patients must provide written or oral informed consent to participate in the registry following the local regulations.
Key inclusion criteria (2 listed)
- All patients must provide written or oral informed consent to participate in the registry depending on the local regulations.
- Patients having received a Sorin Group aortic valve device in accordance with the IFU
Key exclusion criteria (0 listed)
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 rate of valve related major adverse events (MAEs)
Time frame: At 5 years follow-up
To evaluate the composite rate of site reported valve related MAE defined as death, stroke and/or re-intervention (involving surgery or any other invasive therapy) at 5 years follow-up.
7 secondary outcomes
Procedural timings
Time frame: Intra-operative and at 30 days (average)
Clinical success
Time frame: 30 days (average)
Improvement of clinical status
Time frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Echocardiographic evaluation
Time frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
MAE during the duration of the registry
Time frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Composite rate of valve related MAE
Time frame: 4-year, and 7 and 10-year follow-up in selected centers only
Valve-related Serious Adverse Event (SAE)
Time frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Results and safety
The study was stopped early (reason given: Less data return than expected. The new Medical Device Regulation (MDR) implementation prompted the Sponsor to set up a broader scope post-market registry for all Corcym cardiovascular products (MANTRA).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Disease
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruiting
J-Valve Transfemoral Pivotal Study
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
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.
Sara Gaggianesi study director
Corcym S.r.l
52 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Aortic Stenosis, run by Corcym S.r.l at 52 sites in 17 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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Italy, France, United Kingdom, United States, Spain and 12 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?
The study was stopped early (reason given: Less data return than expected. The new Medical Device Regulation (MDR) implementation prompted the Sponsor to set up a broader scope post-market registry for all Corcym cardiovascular products (MANTRA).). Results are not available in the source record.
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?
Composite rate of valve related major adverse events (MAEs) (time frame: At 5 years follow-up). 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 6 Mar 2024.