Pulmonic SAPIEN XT THV (Pulmonic XT)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Valve Malfunction
• Intervention / Treatment: Other: SAPIEN XT

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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • Gent University Hospital
  • Leuven, Belgium
    • UZ Leuven
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St Pauls Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General
  • Quebec
    • Montreal, Quebec, Canada, G1V 4G5
      • Hospital Laval, Ste Foy
• Switzerland
  • Zürich, Switzerland, 8091
    • Universitätshospital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pulmonary valve replacement; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Collaborators: Estimate, GmbH
• Investigators: Principal Investigator: Nikolaus Haas, MD, Center for Congenital Heart Defects, Heart and Diabetes Center NRW; Principal Investigator: Peter Bramlage, MD, IPPMed

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): November 26, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: EU Pulmonic XT