Overview

This trial is active, not recruiting.

Condition pulmonary valve malfunction
Treatment sapien xt
Sponsor Institut für Pharmakologie und Präventive Medizin
Collaborator Estimate, GmbH
Start date November 2014
End date November 2015
Trial size 49 participants
Trial identifier NCT02302131, EU Pulmonic XT

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 XT transcatheter heart valve in the pulmonic position.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Arm
SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
sapien xt
Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection

Primary Outcomes

Measure
right ventricular and pulmonary artery pressure
time frame: 30 days
max flow velocity RVOT
time frame: 30 days
NYHA class
time frame: 30 days
degree of pulmonary regurgitation
time frame: 30 days
procedural success
time frame: 30 days
Peak gradient
time frame: 30 days
length of hospitalization
time frame: 30 days
Peak Oxygen consumption
time frame: 24 months
anaerobic threshold
time frame: 24 months
device function
time frame: 24 months
structural valve Deterioration including stent fracture
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Clinical indication and decision for the implantation of an Edwards SAPIEN XT THV made - Data release form Exclusion Criteria:

Additional Information

Official title Pulmonic SAPIEN XT™ THV A Multi-center, Observational Registry With Retrospective Enrollment of Patients That Underwent Transcatheter Pulmonic Valve Implantation and a Retrospective or Prospective Follow-up
Principal investigator Nikolaus Haas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Institut für Pharmakologie und Präventive Medizin.