Pulmonic Valve REplacement Multi-discIpline EMEA Registry
NCT ID: NCT01356108
Last Updated: 2018-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2011-01-31
2017-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)
The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* RV-PA pulmonary conduit size that is either too large or too small to accommodate the SAPIEN THV.
* Thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve.
* Severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy.
* Active bacterial endocarditis or other active infections.
* Illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery.
* Presence of any prosthetic valve in the tricuspid position.
* Unstable coronary artery disease-related angina.
* Placement of the SAPIEN THV in pregnant females.
19 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Ewert, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum München
Locations
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University Hospital Leuven
Leuven, , Belgium
Herz und Diabeteszentrum NRW
Bad Oeynhausen, , Germany
German Heart Institute Berlin
Berlin, , Germany
Deutsches Herzzentrum München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Mater Misericordiae University Hospital
Dublin, , Ireland
Schneider Children's Medical Center of Israel
Petach Tikvah, , Israel
Ospedale Bambino Gesù
Rome, , Italy
Policlinico San Donato
San Donato Milanese, , Italy
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, , Poland
King Faisal Specialist Hospital & Research Centre
Riyadh, , Saudi Arabia
Prince Sultan Cardiac Centre
Riyadh, , Saudi Arabia
Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery
Istanbul, , Turkey (Türkiye)
Royal Brompton Hospital
London, , United Kingdom
The Heart Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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Other Identifiers
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2010-11
Identifier Type: -
Identifier Source: org_study_id
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