Sorin Universal REgistry on Aortic Valve Replacement

NCT ID: NCT02679404

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2758 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2021-03-31

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.

Conditions

Aortic Valve Disease; Aortic Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcym S.r.l

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara Gaggianesi

Role: STUDY_DIRECTOR

Corcym S.r.l

Locations

Princeton Baptist Med Center

Birmingham, Alabama, United States

River City Clinical Research

Jacksonville, Florida, United States

Columbia University Hospital

New York, New York, United States

Mount Carmel Hospital

Columbus, Ohio, United States

Baylor Scott and White Research Institute

Plano, Texas, United States

Melbourne Private Hospital

Melbourne, , Australia

Royal Melbourne Hospital

Melbourne, , Australia

Hospital Salzburg

Salzburg, , Austria

UCL St Luc

Brussels, , Belgium

CHU Liège

Liège, , Belgium

CHR Namur

Namur, , Belgium

Private cardiac center - Burgas

Burgas, , Bulgaria

Foothill Medical Centre - Calgary, Alberta

Calgary, , Canada

Center of Cardiovascular Surgery and Transplantation Brno

Brno, , Czechia

IKEM - Prague

Prague, , Czechia

CHU Bordeaux

Bordeaux, , France

Clinique Saint Augustin

Bordeaux, , France

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Clinique la Protestante

Lyon, , France

CHU La Timone

Marseille, , France

CHU Rennes

Rennes, , France

Universitätsklinikum Magdeburg

Magdeburg, , Germany

Nuremberg Hospital

Nuremberg, , Germany

Sheba Medical Center

Tel Litwinsky, , Israel

Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

Alessandria, , Italy

Policlinico S.Orsola-Malpighi

Bologna, , Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Città di Lecce Hospital

Lecce, , Italy

Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

Massa, , Italy

Centro Cardiologico Monzino

Milan, , Italy

Istituto Clinico Sant'Ambrogio

Milan, , Italy

Policlinico Paolo Giaccone

Palermo, , Italy

IRCCS Policlinico San Donato

San Donato Milanese, , Italy

Ospedale Ca' Foncello - Treviso

Treviso, , Italy

Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

Trieste, , Italy

Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine

Udine, , Italy

Amphia hospital Breda

Breda, , Netherlands

UMC Groningen

Groningen, , Netherlands

National Heart Centre Singapore

Singapore, , Singapore

Vusch - Kosice

Košice, , Slovakia

Hospital Juan Canalejo

A Coruña, , Spain

Hospital Sant Pau

Barcelona, , Spain

Hospital Reina Sofía

Córdoba, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

University Hospital of Basel

Basel, , Switzerland

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, , Switzerland

Blackpool Teaching Hospital

Blackpool, , United Kingdom

Royal Sussex County Hospital - Brighton

Brighton, , United Kingdom

Bristol Royal Infirmary

Bristol, , United Kingdom

Hammersmith Hospital

London, , United Kingdom

King's College Hospital

London, , United Kingdom

Royal Brompton

London, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Bulgaria; Canada; Czechia; France; Germany; Israel; Italy; Netherlands; Singapore; Slovakia; Spain; Switzerland; United Kingdom

Other Identifiers

APR001

Identifier Type: -

Identifier Source: org_study_id