CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Profile 3D™ and CG Future® annuloplasty systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03283722
NCT03283722N/ACompleted
CompareCT.gov

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

Medtronic Cardiac Surgery·observational·Posted Sep 14, 2017·Updated Feb 11, 2025

In Brief

An observational study evaluating Profile 3D™ and CG Future® annuloplasty system for Mitral Valve Disease. Completed, enrolled 200 participants across 12 sites in 3 countries.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Valve Disease
CountriesBangladesh, India, Nepal
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 14, 2017
Enrollment StartApr 10, 2017
Primary CompletionFeb 10, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.8 years ago

Interventions

Profile 3D™ and CG Future® annuloplasty systemdevice

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