Pulmonic SAPIEN XT THV

Completed

• Conditions: Pulmonary Valve Malfunction
• Interventions: Other: SAPIEN XT

• Registration Number: NCT02302131
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-26
• Primary Completion: 2015-11
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pulmonary valve replacement	SAPIEN XT	SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection

Primary Outcome Measures

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

Trial Locations

Locations (6)

Toronto General; 🇨🇦 Toronto, Ontario, Canada

Hospital Laval, Ste Foy; 🇨🇦 Montreal, Quebec, Canada

UZ Leuven; 🇧🇪 Leuven, Belgium

Gent University Hospital; 🇧🇪 Gent, Belgium

Universitätshospital Zürich; 🇨🇭 Zürich, Switzerland

St Pauls Hospital; 🇨🇦 Vancouver, British Columbia, Canada