Pulmonic SAPIEN XT THV

Pulmonary Valve Malfunction Clinical Trial

— Pulmonic XT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302131
• Other study ID #: EU Pulmonic XT
• Status: Completed
• Phase: N/A
• First received: November 24, 2014
• Last updated: April 4, 2017
• Start date: November 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical indication and decision for the implantation of an Edwards SAPIEN XT THV made

• Data release form

Exclusion Criteria:

Related Conditions & MeSH terms

• Pulmonary Valve Malfunction

Intervention

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

Locations

Country	Name	City	State
Belgium	Gent University Hospital	Gent
Belgium	UZ Leuven	Leuven
Canada	Hospital Laval, Ste Foy	Montreal	Quebec
Canada	Toronto General	Toronto	Ontario
Canada	St Pauls Hospital	Vancouver	British Columbia
Switzerland	Universitätshospital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Estimate, GmbH

Countries where clinical trial is conducted

Belgium,  Canada,  Switzerland, 

Outcome

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