NCT03842397

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Kephalios · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Valve Regurgitation

Interventions

Type	Name	Description
DEVICE	Kephalios Device 1	The Kephalios Device 1 is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of the Kephalios Device 1 is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3

Timeline

• Start date: 2017-12-30
• Primary completion: 2018-07-02
• Completion: 2018-11-28
• First posted: 2019-02-15
• Last updated: 2021-02-26

Locations

1 site across 1 country: Austria