Sorin Universal REgistry on Aortic Valve Replacement (SURE-AVR)

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Stenosis; Aortic Valve Disease

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 Type: Observational
• Enrollment (Actual): 2758

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • Royal Melbourne Hospital
  • Melbourne, Australia
    • Melbourne Private Hospital
• Austria
  • Salzburg, Austria
    • Hospital Salzburg
• Belgium
  • Brussels, Belgium
    • UCL St Luc
  • Liège, Belgium
    • CHU Liege
  • Namur, Belgium
    • CHR Namur
• Bulgaria
  • Burgas, Bulgaria
    • Private cardiac center - Burgas
• Canada
  • Calgary, Canada
    • Foothill Medical Centre - Calgary, Alberta
• Czechia
  • Brno, Czechia
    • Center of Cardiovascular Surgery and Transplantation Brno
  • Prague, Czechia
    • IKEM - Prague
• France
  • Bordeaux, France
    • CHU Bordeaux
  • Bordeaux, France
    • Clinique Saint Augustin
  • Clermont Ferrand, France
    • CHU Clermont-Ferrand
  • Lyon, France
    • Clinique la Protestante
  • Marseille, France
    • CHU La Timone
  • Rennes, France
    • CHU Rennes
• Germany
  • Magdeburg, Germany
    • Universitätsklinikum Magdeburg
  • Nuremberg, Germany
    • Nuremberg Hospital
• Israel
  • Tel HaShomer, Israel
    • Sheba Medical Center
• Italy
  • Alessandria, Italy
    • Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo
  • Bologna, Italy
    • Policlinico S.Orsola-Malpighi
  • Brescia, Italy
    • Fondazione Poliambulanza Istituto Ospedaliero
  • Lecce, Italy
    • Città di Lecce Hospital
  • Massa, Italy, 54100
    • Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa
  • Milan, Italy
    • Centro Cardiologico Monzino
  • Milan, Italy
    • Istituto Clinico Sant'Ambrogio
  • Palermo, Italy
    • Policlinico Paolo Giaccone
  • San Donato Milanese, Italy
    • IRCCS Policlinico San Donato
  • Treviso, Italy
    • Ospedale Ca' Foncello - Treviso
  • Trieste, Italy
    • Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
  • Udine, Italy
    • Azienda Ospedaliero-Universitaria "S. Maria della Misericordia" di Udine
• Netherlands
  • Breda, Netherlands
    • Amphia Hospital Breda
  • Groningen, Netherlands
    • UMC Groningen
• Singapore
  • Singapore, Singapore
    • National Heart Centre Singapore
• Slovakia
  • Košice, Slovakia
    • Vusch - Kosice
• Spain
  • A Coruña, Spain
    • Hospital Juan Canalejo
  • Barcelona, Spain
    • Hospital Sant Pau
  • Córdoba, Spain
    • Hospital Reina Sofía
  • Madrid, Spain
    • Hospital Clínico San Carlos
• Switzerland
  • Basel, Switzerland
    • University Hospital of Basel
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois Lausanne
• United Kingdom
  • Blackpool, United Kingdom
    • Blackpool Teaching Hospital
  • Brighton, United Kingdom
    • Royal Sussex County Hospital - Brighton
  • Bristol, United Kingdom
    • Bristol Royal Infirmary
  • London, United Kingdom
    • King's College Hospital
  • London, United Kingdom
    • Hammersmith Hospital
  • London, United Kingdom
    • Royal Brompton
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Princeton Baptist Med Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • River City Clinical Research
  • New York
    • New York, New York, United States, 10032
      • Columbia University Hospital
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Mount Carmel Hospital
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Scott and White Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural timings	Cross clamp time, intensive care unit and total length of hospital stay.	Intra-operative and at 30 days (average)
Clinical success	The clinical success defined as a successful valve implantation without MAE at hospital discharge.	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.	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.	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.	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.	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.	Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.

Collaborators and Investigators

• Sponsor: Corcym S.r.l
• Investigators: Study Director: Sara Gaggianesi, Corcym S.r.l

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimated): February 10, 2016

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Biological aortic valves; Mechanical aortic valves; Aortic conduits; Sutureless Aortic Valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID Numbers: APR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO