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Studies

Interventional Recruiting

NCT06906926 on ClinicalTrials.gov

Harmony TPV EMEA PMS

Official title: Harmony TPV EMEA Post-Market Study

  • Sponsor: Medtronic (India)
  • Enrollment: 80 (Estimated)
  • Study start: 2025-07-30 (Actual)
  • Primary completion: 2027-07-31 (Estimated)
  • Study completion: 2032-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Severe Pulmonary Valve Regurgitation

Intervention / Treatment

  • Radiation: Certain imaging assessments can be non-Standard of Care

Primary Outcome Measures

  • Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: (6 months)
    * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%

Countries

Denmark, France, Germany, Ireland, Israel, Italy, Spain, Sweden

Locations and Investigators

  • Rigshospitalet, Copenhagen, Denmark (Recruiting)
    • Michael Rahbek Schmidt, Dr.
  • CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque, Bordeaux, France (Recruiting)
    • Jean-Benoit Thambo, Dr.
  • Herz - und Diabeteszentrum NRW, Bad Oeynhausen, Germany (Recruiting)
    • Stephan Schubert, Prof. Dr.
  • Charité - Universitätsmedizin Berlin, Berlin, Germany (Recruiting)
    • Peter Kramer, Dr.
  • Helios Health Institute Standort Leipzig, Leipzig, Germany (Recruiting)
    • Ingo Dähnert, Prof. Dr.
  • TUM University Hospital, Munich, Germany (Recruiting)
    • Peter Ewert, Prof. Dr.
  • Mater Misericordiae University Hospital, Dublin, Ireland (Recruiting)
    • Damien Kenny, Prof. Dr.
  • Schneider Children's Medical Center Israel, Petah Tikva, Israel (Recruiting)
    • Einat Birk, Prof.
  • Policlinico di Sant'Orsola, Bologna, Italy (Recruiting)
    • Andrea Donti, Dr.
  • Azienda Ospedaliera di Padova, Padova, Italy (Not yet recruiting)
    • Biagio Castaldi, Prof.
  • Hospital General Universitario Gregorio Marañón, Madrid, Spain (Recruiting)
    • Ricardo Sanz, Dr.
  • Skånes Universitetssjukhus Lund, Lund, Sweden (Recruiting)
    • Petru Liuba, Prof.

Study Officials

  • Peter Ewert, Prof. Dr. (Principal Investigator) — TUM Klinikum Deutsches Herzzentrum