Pulmonic SAPIEN S3™ THV Registry (PulmonicS3)

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Valve Malfunction; Right Ventricular Outflow Tract (RVOT) Dysfunction
• Intervention / Treatment: Other: Sapien S3

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St Pauls Hospital Vancouver
• Germany
  • Bavaria
    • München, Bavaria, Germany, 80636
      • Deutsches Herzzentrum München
    • München, Bavaria, Germany, 81377
      • Herzchirurgische Klinik und Poliklinik LMU
• Switzerland
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection

Description

Inclusion criteria

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pulmonary valve replacement; SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in right ventricular and pulmonary artery pressure	from baseline to 30 days after implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
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
length of hospitalization	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

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Study Director: Peter Bramlage, Prof MD, Institut für Pharmakologie und Präventive Medizin

Publications and helpful links

Helpful Links

• on-line data entry site

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimated): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pulmonic S3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED