Clinical trial NCT02777892: Pulmonic SAPIEN S3™ THV Registry
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Valve Malfunction
Right Ventricular Outflow Tract (RVOT) Dysfunction
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2016-05-19
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: Inclusion criteria

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

Exclusion Criteria:

* none

Primary outcomes:
measure: changes in right ventricular and pulmonary artery pressure
timeFrame: from baseline to 30 days after implantation
Secondary outcomes:
measure: Max. flow velocity RVOT
timeFrame: 30 days after implantation
measure: Changes in NYHA class
timeFrame: from baseline to 30 days after implantation
measure: changes in degree of pulmonary regurgitation
timeFrame: from baseline to 30 days after implantation
measure: length of hospitalization
timeFrame: 30 days after implantation
measure: changes in Peak Oxygen consumption
timeFrame: from baseline to 24 months after implantation
measure: Percentage of cases with proper device function
timeFrame: 24 months after implantation
measure: Incidence of structural valve Deterioration including stent fracture
timeFrame: 24 months after implantation
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Pauls Hospital Vancouver
state: British Columbia
city: München
country: Germany
facility: Deutsches Herzzentrum München
state: Bavaria
city: München
country: Germany
facility: Herzchirurgische Klinik und Poliklinik LMU
state: Bavaria
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Institut für Pharmakologie und Präventive Medizin
name: Peter Bramlage, Prof MD
role: STUDY_DIRECTOR
References: