UnknownNot Applicable

Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve

France600 participantsStarted 2021-09-01

Plain-language summary

Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right ventricular outflow tract dysfunction in patients with congenital heart diseases. Long-term outcomes following this procedure using the new generation SAPIEN 3 valve is little known. Purpose This study aims to report mid-term outcomes in a large cohort of patients who had TPVI using the SAPIEN 3 valve. Methods We designed a retrospective multicentre observational registry of patients undergoing TPVI with the SAPIEN 3 valve across centres in Europe, Middle-east and Canada. Patient-related, procedural, and mid-term outcomes data will be characterized.

Who can participate

Age range5 Years – 110 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient with congenital heart disease, dysfunctional right ventricle outflow tract and indications for percutaneous pulmonary valve replacement as indicated by international guidelines- * Patient having a valve replacement using a SAPIEN 3 valve Exclusion Criteria: * Patient having a valve replacement using a SAPIEN XT valve * Patient having a valve replacement using a Melody valve * Patient having a valve replacement using a Harmony valve * Patient having a valve replacement using a Venus-P valve * Patient refusing participation to the study

What they're measuring

secondary pulmonary valve replacement

Timeframe: 5 years

Trial details

NCT IDNCT05264181

SponsorCentre Chirurgical Marie Lannelongue

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-01

Contact for this trial

Sebastien Hascoet, MD, PhD

0140942429 s.hascoet@ghpsj.fr

View on ClinicalTrials.gov More Pulmonary Valve; Failure trials