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Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve

NCT05264181 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2022-03-03

No results posted yet for this study

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.

Conditions

  • Pulmonary Valve; Failure
  • Percutaneous Pulmonary Valve Implantation
  • Infective Endocarditis
  • Congenital Heart Disease

Interventions

DEVICE

Percutaneous pulmonary valve implantation

Percutaneous pulmonary valve implantation using SAPIEN 3 valve in the context of routine care of patients with congenital heart diseases

Sponsors & Collaborators

  • Institut für Pharmakologie und Präventive Medizin

    collaborator NETWORK

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

  • Alain Fraisse, MD, PhD · Royal Brompton & Harefield NHS Foundation Trust

Eligibility

Min Age
5 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-03-01
Completion
2022-08-01
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264181 on ClinicalTrials.gov