Pulmonic SAPIEN S3™ THV Registry

Completed

• Conditions: Right Ventricular Outflow Tract (RVOT) Dysfunction; Pulmonary Valve Malfunction
• Interventions: Other: Sapien S3

• Registration Number: NCT02777892
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Primary Completion: 2023-03-31
• Study Completion: 2023-07-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pulmonary valve replacement	Sapien S3	SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection

Primary Outcome Measures

Name	Time	Method
changes in right ventricular and pulmonary artery pressure	from baseline to 30 days after implantation

Secondary Outcome Measures

Name	Time	Method
Max. flow velocity RVOT	30 days after implantation
Changes in NYHA class	from baseline to 30 days after implantation
changes in degree of pulmonary regurgitation	from baseline to 30 days after implantation
changes in Peak Oxygen consumption	from baseline to 24 months after implantation
Percentage of cases with proper device function	24 months after implantation
Incidence of structural valve Deterioration including stent fracture	24 months after implantation
length of hospitalization	30 days after implantation

Trial Locations

Locations (4)

St Pauls Hospital Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

Universitätsspital Zürich; 🇨🇭 Zürich, Switzerland

Herzchirurgische Klinik und Poliklinik LMU; 🇩🇪 München, Bavaria, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Bavaria, Germany