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Clinical Trial Summary

The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure


Clinical Trial Description

There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes. Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation. PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03283722
Study type Observational
Source Medtronic Cardiac Surgery
Contact
Status Completed
Phase
Start date September 22, 2017
Completion date February 10, 2021

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