Sorin Universal REgistry on Aortic Valve Replacement

NCT02679404 | Terminated

• 1 other identifier: APR001
• Study Type: observational
• Target: 2,758
• Locations: 16 countries
• Sites: 51

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.

Conditions

Aortic Valve Disease; Aortic Stenosis

Keywords

Biological aortic valves; Mechanical aortic valves; Aortic conduits; Sutureless Aortic Valve

Outcome Measures

Primary Outcomes (1)

• 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.

  At 5 years follow-up

Secondary Outcomes (7)

• Procedural timings

  Intra-operative and at 30 days (average)

• Clinical success

  30 days (average)

• Improvement of clinical status

  Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.

• Echocardiographic evaluation

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Corcym S.r.l: lead

Study Sites (52)

Princeton Baptist Med Center

Birmingham, Alabama, 35211, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Columbia University Hospital

New York, New York, 10032, United States

Location

Mount Carmel Hospital

Columbus, Ohio, 43213, United States

Location

Baylor Scott and White Research Institute

Plano, Texas, 75093, United States

Location

Melbourne Private Hospital

Melbourne, Australia

Location

Royal Melbourne Hospital

Melbourne, Australia

Location

Hospital Salzburg

Salzburg, Austria

Location

UCL St Luc

Brussels, Belgium

Location

CHU Liège

Liège, Belgium

Location

CHR Namur

Namur, Belgium

Location

Private cardiac center - Burgas

Burgas, Bulgaria

Location

Foothill Medical Centre - Calgary, Alberta

Calgary, Canada

Location

Center of Cardiovascular Surgery and Transplantation Brno

Brno, Czechia

Location

IKEM - Prague

Prague, Czechia

Location

CHU Bordeaux

Bordeaux, France

Location

Clinique Saint Augustin

Bordeaux, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Clinique la Protestante

Lyon, France

Location

CHU La Timone

Marseille, France

Location

CHU Rennes

Rennes, France

Location

Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Nuremberg Hospital

Nuremberg, Germany

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

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

Alessandria, Italy

Location

Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

Location

Città di Lecce Hospital

Lecce, Italy

Location

Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

Massa, 54100, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Istituto Clinico Sant'Ambrogio

Milan, Italy

Location

Policlinico Paolo Giaccone

Palermo, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Location

Ospedale Ca' Foncello - Treviso

Treviso, Italy

Location

Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

Trieste, Italy

Location

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

Udine, Italy

Location

Amphia hospital Breda

Breda, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

National Heart Centre Singapore

Singapore, Singapore

Location

Vusch - Kosice

Košice, Slovakia

Location

Hospital Juan Canalejo

A Coruña, Spain

Location

Hospital Sant Pau

Barcelona, Spain

Location

Hospital Reina Sofía

Córdoba, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

University Hospital of Basel

Basel, Switzerland

Location

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, Switzerland

Location

Blackpool Teaching Hospital

Blackpool, United Kingdom

Location

Royal Sussex County Hospital - Brighton

Brighton, United Kingdom

Location

Bristol Royal Infirmary

Bristol, United Kingdom

Location

Hammersmith Hospital

London, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Royal Brompton

London, United Kingdom

Location

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Sara Gaggianesi

  Corcym S.r.l

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 10, 2016
• Study Start: May 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); FR (6); IL (1); US (5); CA (1); AU (2); IT (12); NL (2); ES (4); SG (1); BU (1); CH (2); SL (1); CZ (2); GB (6); DE (2)