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Pulmonic SAPIEN S3™ THV Registry (PulmonicS3)

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ClinicalTrials.gov Identifier: NCT02777892
Recruitment Status : Active, not recruiting
First Posted : May 19, 2016
Last Update Posted : February 26, 2019
Sponsor:
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 S3 transcatheter heart valve in the pulmonic position


Condition or disease Intervention/treatment
Pulmonary Valve Malfunction Right Ventricular Outflow Tract (RVOT) Dysfunction Other: Sapien S3

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
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pulmonic SAPIEN S3™ THV Registry 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 : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
pulmonary valve replacement
SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection
Other: Sapien S3
Patients that have undergone percutaneous implantation of an Edwards SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection




Primary Outcome Measures :
  1. changes in right ventricular and pulmonary artery pressure [ Time Frame: from baseline to 30 days after implantation ]

Secondary Outcome Measures :
  1. Max. flow velocity RVOT [ Time Frame: 30 days after implantation ]
  2. Changes in NYHA class [ Time Frame: from baseline to 30 days after implantation ]
  3. changes in degree of pulmonary regurgitation [ Time Frame: from baseline to 30 days after implantation ]
  4. length of hospitalization [ Time Frame: 30 days after implantation ]
  5. changes in Peak Oxygen consumption [ Time Frame: from baseline to 24 months after implantation ]
  6. Percentage of cases with proper device function [ Time Frame: 24 months after implantation ]
  7. Incidence of structural valve Deterioration including stent fracture [ Time Frame: 24 months after implantation ]


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Ages Eligible for Study:   Child, 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 3 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): NCT02777892


Locations
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Canada, British Columbia
St Pauls Hospital Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Germany
Deutsches Herzzentrum München
München, Bavaria, Germany, 80636
Herzchirurgische Klinik und Poliklinik LMU
München, Bavaria, Germany, 81377
Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Investigators
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Study Director: Peter Bramlage, Prof MD Institut für Pharmakologie und Präventive Medizin

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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT02777892     History of Changes
Other Study ID Numbers: Pulmonic S3
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided