An observational study in Pulmonary Valve Malfunction, sponsored by Institut für Pharmakologie und Präventive Medizin. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
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.
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.
Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 29 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
Exclusion Criteria:
SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
Other: 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
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
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut für Pharmakologie und Präventive Medizin