Sorin Universal REgistry on Aortic Valve Replacement

Aortic Stenosis Clinical Trial

— SURE-AVR  

Official title:

Sorin Universal REgistry on Aortic Valve Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02679404
• Other study ID #: APR001
• Status: Terminated
• Start date: May 2015
• Est. completion date: March 2021

Study information

• Verified date: March 2024
• Source: Corcym S.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2758
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Disease
• Aortic Valve Stenosis

Locations

Country	Name	City	State
Australia	Melbourne Private Hospital	Melbourne
Australia	Royal Melbourne Hospital	Melbourne
Austria	Hospital Salzburg	Salzburg
Belgium	UCL St Luc	Brussels
Belgium	CHU Liège	Liège
Belgium	CHR Namur	Namur
Bulgaria	Private cardiac center - Burgas	Burgas
Canada	Foothill Medical Centre - Calgary, Alberta	Calgary
Czechia	Center of Cardiovascular Surgery and Transplantation Brno	Brno
Czechia	IKEM - Prague	Prague
France	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
Germany	Universitätsklinikum Magdeburg	Magdeburg
Germany	Nuremberg Hospital	Nuremberg
Israel	Sheba Medical Center	Tel HaShomer
Italy	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
Netherlands	Amphia hospital Breda	Breda
Netherlands	UMC Groningen	Groningen
Singapore	National Heart Centre Singapore	Singapore
Slovakia	Vusch - Kosice	Košice
Spain	Hospital Juan Canalejo	A Coruña
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Clínico San Carlos	Madrid
Switzerland	University Hospital of Basel	Basel
Switzerland	Centre Hospitalier Universitaire Vaudois Lausanne	Lausanne
United Kingdom	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 States	Princeton Baptist Med Center	Birmingham	Alabama
United States	Mount Carmel Hospital	Columbus	Ohio
United States	River City Clinical Research	Jacksonville	Florida
United States	Columbia University Hospital	New York	New York
United States	Baylor Scott and White Research Institute	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Corcym S.r.l

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedural timings	Cross clamp time, intensive care unit and total length of hospital stay.	Intra-operative and at 30 days (average)
Secondary	Clinical success	The clinical success defined as a successful valve implantation without MAE at hospital discharge.	30 days (average)
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.