NCT06906926

Harmony TPV EMEA PMS

Harmony TPV EMEA Post-Market Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.

Detailed description

Prospective, non-randomized, multi-center, post-market interventional clinical study

Conditions

• Severe Pulmonary Valve Regurgitation

Interventions

Type	Name	Description
RADIATION	Certain imaging assessments can be non-Standard of Care	Pre-Implant CT, Chest X-Ray at discharge and any related assessments during the following up visit, can be non-standard of care depending on site's / countries.

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-07-31
• Completion: 2032-12-31
• First posted: 2025-04-02
• Last updated: 2025-12-22

Locations

12 sites across 8 countries: Denmark, France, Germany, Ireland, Israel, Italy, Spain, Sweden

Regulatory

• FDA-regulated device study