Pulmonic SAPIEN S3™ THV Registry

Pulmonary Valve Malfunction Clinical Trial

— PulmonicS3  

Official title:

Pulmonic SAPIEN S3™ THV Registry A Multi-center, Observational Registry With Retrospective Enrollment of Patients That Underwent Transcatheter Pulmonic Valve Implantation and a Retrospective or Prospective Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777892
• Other study ID #: Pulmonic S3
• Status: Completed
• Start date: March 2016
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria

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

• Data release form

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Pulmonary Valve Malfunction
• Right Ventricular Outflow Tract (RVOT) Dysfunction

Intervention

Other:
• Sapien S3
Patients that have undergone percutaneous implantation of an Edwards SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection

Locations

Country	Name	City	State
Canada	St Pauls Hospital Vancouver	Vancouver	British Columbia
Germany	Deutsches Herzzentrum München	München	Bavaria
Germany	Herzchirurgische Klinik und Poliklinik LMU	München	Bavaria
Switzerland	Universitätsspital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin

Countries where clinical trial is conducted

Canada,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in right ventricular and pulmonary artery pressure		from baseline to 30 days after implantation
Secondary	Max. flow velocity RVOT		30 days after implantation
Secondary	Changes in NYHA class		from baseline to 30 days after implantation
Secondary	changes in degree of pulmonary regurgitation		from baseline to 30 days after implantation
Secondary	length of hospitalization		30 days after implantation
Secondary	changes in Peak Oxygen consumption		from baseline to 24 months after implantation
Secondary	Percentage of cases with proper device function		24 months after implantation
Secondary	Incidence of structural valve Deterioration including stent fracture		24 months after implantation

External Links

•   on-line data entry site