Clinical trial NCT02302131: Pulmonic SAPIEN XT THV
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Valve Malfunction
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Estimate, GmbH
First posted: 2014-11-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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 XT 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 XT THV made
* Data release form

Exclusion Criteria:

* none

Primary outcomes:
measure: right ventricular and pulmonary artery pressure
timeFrame: 30 days
measure: max flow velocity RVOT
timeFrame: 30 days
measure: NYHA class
timeFrame: 30 days
measure: degree of pulmonary regurgitation
timeFrame: 30 days
measure: procedural success
timeFrame: 30 days
measure: Peak gradient
timeFrame: 30 days
measure: length of hospitalization
timeFrame: 30 days
measure: Peak Oxygen consumption
timeFrame: 24 months
measure: anaerobic threshold
timeFrame: 24 months
measure: device function
timeFrame: 24 months
measure: structural valve Deterioration including stent fracture
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Gent University Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
city: Vancouver
country: Canada
facility: St Pauls Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General
state: Ontario
city: Montreal
country: Canada
facility: Hospital Laval, Ste Foy
state: Quebec
city: Zürich
country: Switzerland
facility: Universitätshospital Zürich
Study officials:
affiliation: Center for Congenital Heart Defects, Heart and Diabetes Center NRW
name: Nikolaus Haas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IPPMed
name: Peter Bramlage, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas NA, Carere RG, Kretschmar O, Horlick E, Rodes-Cabau J, de Wolf D, Gewillig M, Mullen M, Lehner A, Deutsch C, Bramlage P, Ewert P. Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system. Int J Cardiol. 2018 Jan 1;250:86-91. doi: 10.1016/j.ijcard.2017.10.015. Epub 2017 Oct 6.