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Completed

NCT Number: NCT02302131

Pulmonic SAPIEN XT THV

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.

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Key information

Conditions

Pulmonary Valve Malfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gent University Hospital, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

SAPIEN XT

Other

Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection

Primary outcomes

  1. right ventricular and pulmonary artery pressure

    Time frame: 30 days

  2. max flow velocity RVOT

    Time frame: 30 days

  3. NYHA class

    Time frame: 30 days

  4. degree of pulmonary regurgitation

    Time frame: 30 days

  5. procedural success

    Time frame: 30 days

  6. Peak gradient

    Time frame: 30 days

  7. length of hospitalization

    Time frame: 30 days

  8. Peak Oxygen consumption

    Time frame: 24 months

  9. anaerobic threshold

    Time frame: 24 months

  10. device function

    Time frame: 24 months

  11. structural valve Deterioration including stent fracture

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Estimate, GmbH

Registry information

Official study 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

Acronym: Pulmonic XT

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Nov 26, 2014
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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