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OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation

Mitral Valve Regurgitation Clinical Trial

Official title:
OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety Evaluation (OPTIMISE)

Clinical Trial Summary

The optimal surgical approach in functional mitral regurgitation (MI) was questioned in favour for prosthetic replacement due to the reduced risk of recurrent MI . However, adjustable mitral rings may provide an alternative . In this first-in-man trial, a novel balloon-adjustable mitral-ring was assessed regarding clinical safety and feasibility. 5 patients will be enrolled according to the inclusion/ exclusion criteria and subsequently implanted with the study device. Study visits will be performed preoperatively, perioperatively, at discharge, at 30 days, 3 months and 6 months. Primary outcome parameter will be morbidity and mortality at 30 days following implantation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03842397
Study type Interventional
Source Affluent Medical
Contact
Status Completed
Phase N/A
Start date December 30, 2017
Completion date November 28, 2018
View Details
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