NCT04147884

A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation

A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation: (Millipede Feasibility Study)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation

Detailed description

The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility/performance of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The study will include subjects with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) despite guideline directed medical therapy in whom the local hearth team determines that surgery is not an option for mitral valve repair. Clinical follow-up will be required in hospital, 30 days, 90 days, 6 months, 12 months, and then annually through 5 years post-procedure. Subjects who have any part of the Millipede Transcatheter Annuloplasty Ring System introduced into the body but who do not end up with an implant will be followed through 30 days.

Conditions

• Mitral Regurgitation Functional
• Mitral Valve Disease
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Millipede Transcatheter Annuloplasty Ring System (Millipede System)	The Millipede Transcatheter Annuloplasty Ring System is a repair device used for treating mitral valve regurgitation (MR). The system consists of several components: a transcatheter annuloplasty ring (implant) which remains in the body and a delivery system and intracardiac echocardiography catheter (imaging device) used to deliver the implant to the mitral valve.

Timeline

• Start date: 2019-11-13
• Primary completion: 2021-12-17
• Completion: 2026-11-01
• First posted: 2019-11-01
• Last updated: 2025-12-23

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study