NCT05496998

Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Detailed description

Prospective, single-arm, multi-center, interventional, pre-market trial

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	Medtronic Intrepid™ TMVR TF System	Patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System

Timeline

• Start date: 2023-02-07
• Primary completion: 2029-08-01
• Completion: 2038-12-01
• First posted: 2022-08-11
• Last updated: 2025-12-17

Locations

37 sites across 8 countries: Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study