NCT03283722

PRESERVE-MITRAL Post-Market Registry

Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Medtronic Cardiac Surgery · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed 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 This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trail was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Heath Service Act or 42 CRF 11.24 and 11.44.)

Conditions

• Mitral Valve Disease

Interventions

Type	Name	Description
DEVICE	Profile 3D™ and CG Future® annuloplasty system	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

Timeline

• Start date: 2017-04-10
• Primary completion: 2021-02-10
• Completion: 2021-02-10
• First posted: 2017-09-14
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

12 sites across 3 countries: Bangladesh, India, Nepal