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Pulmonic SAPIEN S3™ THV Registry (PulmonicS3)

I

Institut für Pharmakologie und Präventive Medizin

Status

Completed

Conditions

Pulmonary Valve Malfunction
Right Ventricular Outflow Tract (RVOT) Dysfunction

Treatments

Other: Sapien S3

Study type

Observational

Funder types

NETWORK

Identifiers

NCT02777892
Pulmonic S3

Details and patient eligibility

About

Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.

The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN S3 transcatheter heart valve in the pulmonic position

Full description

A malfunction or dysplasia of the pulmonary valve or the right ventricular outflow tract (RVOT) is one of the major components of the cardiac physiology in many congenital heart defects. Surgical correction of complex heart defects often includes some form of surgical repair or replacement of the native RVOT by biological valves such as homograft, bioprosthesis or Xenografts (i.e., Contegra conduits). Typical examples are tetralogy of Fallot (TOF) or double outlet right ventricle (DORV), pulmonary stenosis (PS), pulmonary atresia (PA), truncus arteriosus (TA), transposition of the great arteries (TGA) with PS (Rastelli's operation), absent pulmonary valve syndrome (Miller-Lev-Paul), Ross surgery for aortic valve disease and others. The repaired or replaced pulmonary valve however often becomes dysfunctional later on and many patients require surgical revisions of the RVOT with pulmonary valve replacement within 10 years of primary intervention.

TPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Early results of percutaneous pulmonary valve implantation (PPVI) showed that it is a promising procedure compared to a conventional surgical intervention. Meanwhile, pre-stenting of the RVOT before PPVI is routinely performed, enabling PPVI in various anatomies.

Enrollment

50 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Clinical indication and decision for the implantation of an Edwards SAPIEN 3 THV made
  • Data release form

Exclusion Criteria:

  • none

Trial design

50 participants in 1 patient group

pulmonary valve replacement
Description:
SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection
Treatment:
Other: Sapien S3

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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