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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02679404




Registration number
NCT02679404
Ethics application status
Date submitted
27/01/2016
Date registered
10/02/2016
Date last updated
6/03/2024

Titles & IDs
Public title
Sorin Universal REgistry on Aortic Valve Replacement
Scientific title
Sorin Universal REgistry on Aortic Valve Replacement
Secondary ID [1] 0 0
APR001
Universal Trial Number (UTN)
Trial acronym
SURE-AVR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Disease 0 0
Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite rate of valve related major adverse events (MAEs)
Timepoint [1] 0 0
At 5 years follow-up
Secondary outcome [1] 0 0
Procedural timings
Timepoint [1] 0 0
Intra-operative and at 30 days (average)
Secondary outcome [2] 0 0
Clinical success
Timepoint [2] 0 0
30 days (average)
Secondary outcome [3] 0 0
Improvement of clinical status
Timepoint [3] 0 0
Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Secondary outcome [4] 0 0
Echocardiographic evaluation
Timepoint [4] 0 0
Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Secondary outcome [5] 0 0
MAE during the duration of the registry
Timepoint [5] 0 0
Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.
Secondary outcome [6] 0 0
Composite rate of valve related MAE
Timepoint [6] 0 0
4-year, and 7 and 10-year follow-up in selected centers only
Secondary outcome [7] 0 0
Valve-related Serious Adverse Event (SAE)
Timepoint [7] 0 0
Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.

Eligibility
Key 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 age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NA

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2021
Sample size
Target
Accrual to date
Final
2758
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne Private Hospital - Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Liège
Country [9] 0 0
Belgium
State/province [9] 0 0
Namur
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Burgas
Country [11] 0 0
Canada
State/province [11] 0 0
Calgary
Country [12] 0 0
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Prague
Country [14] 0 0
France
State/province [14] 0 0
Bordeaux
Country [15] 0 0
France
State/province [15] 0 0
Clermont Ferrand
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
State/province [18] 0 0
Rennes
Country [19] 0 0
Germany
State/province [19] 0 0
Magdeburg
Country [20] 0 0
Germany
State/province [20] 0 0
Nuremberg
Country [21] 0 0
Israel
State/province [21] 0 0
Tel HaShomer
Country [22] 0 0
Italy
State/province [22] 0 0
Alessandria
Country [23] 0 0
Italy
State/province [23] 0 0
Bologna
Country [24] 0 0
Italy
State/province [24] 0 0
Brescia
Country [25] 0 0
Italy
State/province [25] 0 0
Lecce
Country [26] 0 0
Italy
State/province [26] 0 0
Massa
Country [27] 0 0
Italy
State/province [27] 0 0
Milan
Country [28] 0 0
Italy
State/province [28] 0 0
Palermo
Country [29] 0 0
Italy
State/province [29] 0 0
San Donato Milanese
Country [30] 0 0
Italy
State/province [30] 0 0
Treviso
Country [31] 0 0
Italy
State/province [31] 0 0
Trieste
Country [32] 0 0
Italy
State/province [32] 0 0
Udine
Country [33] 0 0
Netherlands
State/province [33] 0 0
Breda
Country [34] 0 0
Netherlands
State/province [34] 0 0
Groningen
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
Slovakia
State/province [36] 0 0
Košice
Country [37] 0 0
Spain
State/province [37] 0 0
A Coruña
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Córdoba
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Switzerland
State/province [41] 0 0
Basel
Country [42] 0 0
Switzerland
State/province [42] 0 0
Lausanne
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Blackpool
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Brighton
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Bristol
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Corcym S.r.l
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02679404
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sara Gaggianesi
Address 0 0
Corcym S.r.l
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02679404