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Study identifier: NCT06906926 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Harmony TPV EMEA PMS

Condition: Severe Pulmonary Valve Regurgitation  ·  Sponsor: Medtronic Cardiovascular

PhaseNA
Planned participants80
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Petra Novakova  ·  +31612591883  ·  rs.harmonyemeapms@medtronic.com

Always discuss trial participation with your own doctor first.

Locations (12)

RigshospitaletCopenhagen, DenmarkRecruiting
CHU de Bordeaux - Hôpital Cardiologique du Haut-LevequeBordeaux, FranceRecruiting
Herz - und Diabeteszentrum NRWBad Oeynhausen, GermanyRecruiting
Charité - Universitätsmedizin BerlinBerlin, GermanyRecruiting
Helios Health Institute Standort LeipzigLeipzig, GermanyRecruiting
TUM University HospitalMunich, GermanyRecruiting
Mater Misericordiae University HospitalDublin, IrelandRecruiting
Schneider Children's Medical Center IsraelPetah Tikva, IsraelRecruiting
Policlinico di Sant'OrsolaBologna, ItalyRecruiting
Azienda Ospedaliera di PadovaPadova, ItalyNot Yet Recruiting
Hospital General Universitario Gregorio MarañónMadrid, SpainRecruiting
Skånes Universitetssjukhus LundLund, SwedenRecruiting

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Source record: clinicaltrials.gov/study/NCT06906926