Sorin Universal REgistry on Aortic Valve Replacement
- Conditions
- Aortic Valve DiseaseAortic Stenosis
- Registration Number
- NCT02679404
- Lead Sponsor
- Corcym S.r.l
- Brief 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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2758
- 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
NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite rate of valve related major adverse events (MAEs) 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.
- Secondary Outcome Measures
Name Time Method Echocardiographic evaluation Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. 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.
Composite rate of valve related MAE 4-year, and 7 and 10-year follow-up in selected centers only 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.
Clinical success 30 days (average) The clinical success defined as a successful valve implantation without MAE at hospital discharge.
Procedural timings Intra-operative and at 30 days (average) Cross clamp time, intensive care unit and total length of hospital stay.
Improvement of clinical status Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. 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.
Valve-related Serious Adverse Event (SAE) Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. 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.
MAE during the duration of the registry Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only. All site reported MAE rates during the duration of the registry.
Trial Locations
- Locations (52)
CHR Namur
🇧🇪Namur, Belgium
Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
🇮🇹Massa, Italy
Mount Carmel Hospital
🇺🇸Columbus, Ohio, United States
Foothill Medical Centre - Calgary, Alberta
🇨🇦Calgary, Canada
Clinique Saint Augustin
🇫🇷Bordeaux, France
Città di Lecce Hospital
🇮🇹Lecce, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo
🇮🇹Alessandria, Italy
Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine
🇮🇹Udine, Italy
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Princeton Baptist Med Center
🇺🇸Birmingham, Alabama, United States
Melbourne Private Hospital
🇦🇺Melbourne, Australia
Columbia University Hospital
🇺🇸New York, New York, United States
River City Clinical Research
🇺🇸Jacksonville, Florida, United States
Baylor Scott and White Research Institute
🇺🇸Plano, Texas, United States
Royal Melbourne Hospital
🇦🇺Melbourne, Australia
CHU Liège
🇧🇪Liège, Belgium
UCL St Luc
🇧🇪Brussels, Belgium
Hospital Salzburg
🇦🇹Salzburg, Austria
Private cardiac center - Burgas
🇧🇬Burgas, Bulgaria
CHU Bordeaux
🇫🇷Bordeaux, France
Center of Cardiovascular Surgery and Transplantation Brno
🇨🇿Brno, Czechia
IKEM - Prague
🇨🇿Prague, Czechia
CHU Clermont-Ferrand
🇫🇷Clermont Ferrand, France
Clinique la Protestante
🇫🇷Lyon, France
CHU La Timone
🇫🇷Marseille, France
CHU Rennes
🇫🇷Rennes, France
Nuremberg Hospital
🇩🇪Nuremberg, Germany
Policlinico S.Orsola-Malpighi
🇮🇹Bologna, Italy
Universitätsklinikum Magdeburg
🇩🇪Magdeburg, Germany
Fondazione Poliambulanza Istituto Ospedaliero
🇮🇹Brescia, Italy
Sheba Medical Center
🇮🇱Tel HaShomer, Israel
Centro Cardiologico Monzino
🇮🇹Milan, Italy
Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Istituto Clinico Sant'Ambrogio
🇮🇹Milan, Italy
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Italy
Ospedale Ca' Foncello - Treviso
🇮🇹Treviso, Italy
Vusch - Kosice
🇸🇰Košice, Slovakia
Hospital Juan Canalejo
🇪🇸A Coruña, Spain
Amphia hospital Breda
🇳🇱Breda, Netherlands
UMC Groningen
🇳🇱Groningen, Netherlands
Hospital Sant Pau
🇪🇸Barcelona, Spain
Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
🇮🇹Trieste, Italy
University Hospital of Basel
🇨🇭Basel, Switzerland
Blackpool Teaching Hospital
🇬🇧Blackpool, United Kingdom
Centre Hospitalier Universitaire Vaudois Lausanne
🇨🇭Lausanne, Switzerland
Hospital Reina Sofía
🇪🇸Córdoba, Spain
Royal Sussex County Hospital - Brighton
🇬🇧Brighton, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Royal Brompton
🇬🇧London, United Kingdom
Hospital Clínico San Carlos
🇪🇸Madrid, Spain