Pulmonic SAPIEN XT THV

NCT ID: NCT02302131

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-04-30

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.

Conditions

Pulmonary Valve Malfunction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

pulmonary valve replacement

SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection

SAPIEN XT

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Estimate, GmbH

INDUSTRY

Sponsor Role: collaborator

Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nikolaus Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Congenital Heart Defects, Heart and Diabetes Center NRW

Peter Bramlage, MD

Role: PRINCIPAL_INVESTIGATOR

IPPMed

Locations

Gent University Hospital

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

St Pauls Hospital

Vancouver, British Columbia, Canada

Toronto General

Toronto, Ontario, Canada

Hospital Laval, Ste Foy

Montreal, Quebec, Canada

Universitätshospital Zürich

Zurich, Canton of Zurich, Switzerland

Countries

Belgium; Canada; Switzerland

References

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.

Reference Type: DERIVED

PMID: 29017776 (View on PubMed)

Other Identifiers

EU Pulmonic XT

Identifier Type: -

Identifier Source: org_study_id