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Pulmonic SAPIEN XT THV (Pulmonic XT)

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ClinicalTrials.gov Identifier: NCT02302131
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Estimate, GmbH
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Pulmonary Valve Malfunction 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 49 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 24 Months
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
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : April 2017

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302131


Locations
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Belgium
Gent University Hospital
Gent, Belgium
UZ Leuven
Leuven, Belgium
Canada, British Columbia
St Pauls Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Toronto General
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hospital Laval, Ste Foy
Montreal, Quebec, Canada, G1V 4G5
Switzerland
Universitätshospital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Estimate, GmbH
Investigators
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Principal Investigator: Nikolaus Haas, MD Center for Congenital Heart Defects, Heart and Diabetes Center NRW
Principal Investigator: Peter Bramlage, MD IPPMed

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT02302131     History of Changes
Other Study ID Numbers: EU Pulmonic XT
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017