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
1 other identifier
observational
49
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2014
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 24, 2014
CompletedFirst Posted
Study publicly available on registry
November 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 5, 2017
April 1, 2017
1 year
November 24, 2014
April 4, 2017
Conditions
Outcome Measures
Primary Outcomes (11)
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
Study Arms (1)
pulmonary valve replacement
SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
Interventions
Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
Eligibility Criteria
Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
You may qualify if:
- Clinical indication and decision for the implantation of an Edwards SAPIEN XT THV made
- Data release form
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut für Pharmakologie und Präventive Medizinlead
- Estimate, GmbHcollaborator
Study Sites (6)
Gent University Hospital
Ghent, Belgium
UZ Leuven
Leuven, Belgium
St Pauls Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Toronto General
Toronto, Ontario, M5G 2C4, Canada
Hospital Laval, Ste Foy
Montreal, Quebec, G1V 4G5, Canada
Universitätshospital Zürich
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 29017776DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Nikolaus Haas, MD
Center for Congenital Heart Defects, Heart and Diabetes Center NRW
- PRINCIPAL INVESTIGATOR
Peter Bramlage, MD
IPPMed
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Target Duration
- 24 Months
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2014
First Posted
November 26, 2014
Study Start
November 1, 2014
Primary Completion
November 1, 2015
Study Completion
April 1, 2017
Last Updated
April 5, 2017
Record last verified: 2017-04