Clinical trial NCT02679404: Sorin Universal REgistry on Aortic Valve Replacement
Official title: Sorin Universal REgistry on Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Disease
Aortic Stenosis
Keywords: Biological aortic valves
Mechanical aortic valves
Aortic conduits
Sutureless Aortic Valve
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
First posted: 2016-02-10
Enrollment: 2758
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria: NA

Primary outcomes:
measure: Composite rate of valve related major adverse events (MAEs)
timeFrame: At 5 years follow-up
Secondary outcomes:
measure: Procedural timings
timeFrame: Intra-operative and at 30 days (average)
measure: Clinical success
timeFrame: 30 days (average)
measure: Improvement of clinical status
timeFrame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
measure: Echocardiographic evaluation
timeFrame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
measure: MAE during the duration of the registry
timeFrame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
measure: Composite rate of valve related MAE
timeFrame: 4-year, and 7 and 10-year follow-up in selected centers only
measure: Valve-related Serious Adverse Event (SAE)
timeFrame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Princeton Baptist Med Center
state: Alabama
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: New York
country: United States
facility: Columbia University Hospital
state: New York
city: Columbus
country: United States
facility: Mount Carmel Hospital
state: Ohio
city: Plano
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Melbourne
country: Australia
facility: Melbourne Private Hospital
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Salzburg
country: Austria
facility: Hospital Salzburg
city: Brussels
country: Belgium
facility: UCL St Luc
city: Liège
country: Belgium
facility: CHU Liège
city: Namur
country: Belgium
facility: CHR Namur
city: Burgas
country: Bulgaria
facility: Private cardiac center - Burgas
city: Calgary
country: Canada
facility: Foothill Medical Centre - Calgary, Alberta
city: Brno
country: Czechia
facility: Center of Cardiovascular Surgery and Transplantation Brno
city: Prague
country: Czechia
facility: IKEM - Prague
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Clermont Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lyon
country: France
facility: Clinique la Protestante
city: Marseille
country: France
facility: CHU La Timone
city: Rennes
country: France
facility: CHU Rennes
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Nuremberg
country: Germany
facility: Nuremberg Hospital
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
city: Lecce
country: Italy
facility: Città di Lecce Hospital
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Milan
country: Italy
facility: Istituto Clinico Sant'Ambrogio
city: Palermo
country: Italy
facility: Policlinico Paolo Giaccone
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello - Treviso
city: Trieste
country: Italy
facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine
city: Breda
country: Netherlands
facility: Amphia hospital Breda
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Košice
country: Slovakia
facility: Vusch - Kosice
city: A Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Basel
country: Switzerland
facility: University Hospital of Basel
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois Lausanne
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital - Brighton
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Brompton
Study officials:
affiliation: Corcym S.r.l
name: Sara Gaggianesi
role: STUDY_DIRECTOR
References: