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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	18 March 2024
Main ID:	NCT02679404
Date of registration:	27/01/2016
Prospective Registration:	No
Primary sponsor:	Corcym S.r.l
Public title:	Sorin Universal REgistry on Aortic Valve Replacement SURE-AVR
Scientific title:	Sorin Universal REgistry on Aortic Valve Replacement
Date of first enrolment:	May 2015
Target sample size:	2758
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/ct2/show/NCT02679404
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Australia	Austria	Belgium	Bulgaria	Canada	Czech Republic	Czechia	France
Germany	Israel	Italy	Netherlands	Singapore	Slovakia	Spain	Switzerland
United Kingdom	United States

Contacts

Name:	Sara Gaggianesi
Address:
Telephone:
Email:
Affiliation:	Corcym S.r.l

Key inclusion & exclusion 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

Exclusion Criteria: NA

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Aortic Stenosis

Aortic Valve Disease

Intervention(s)

Primary Outcome(s)

Composite rate of valve related major adverse events (MAEs) [Time Frame: At 5 years follow-up]

Secondary Outcome(s)

Valve-related Serious Adverse Event (SAE) [Time Frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.]

Clinical success [Time Frame: 30 days (average)]

Composite rate of valve related MAE [Time Frame: 4-year, and 7 and 10-year follow-up in selected centers only]

Echocardiographic evaluation [Time Frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.]

Improvement of clinical status [Time Frame: 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 [Time Frame: Annually through a 5-year follow-up, and 7 and 10-year follow-up in selected centers only.]

Procedural timings [Time Frame: Intra-operative and at 30 days (average)]

Secondary ID(s)

APR001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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