Clinical trial NCT01356108: Pulmonic Valve REplacement Multi-discIpline EMEA Registry
Official title: Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Regurgitation
Pulmonary Insufficiency
Pulmonary Stenosis
Keywords: Conduit
Pulmonic
Stenosis
Regurgitation
Dysfunctional
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 127
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All symptomatic patients with a regurgitant or stenotic pulmonary valved conduit treated by implantation of the Edwards SAPIEN™ THV.

Brief summary: The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.

Detailed description: Consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.

Eligibility criteria: Inclusion Criteria:

- Symptomatic with a regurgitant or stenotic pulmonary valved conduit.

Exclusion Criteria:

* Angiographic evidence of coronary artery compression.
* 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.

Primary outcomes:
measure: Safety
timeFrame: 6 months
Secondary outcomes:
measure: Safety and Effectiveness
timeFrame: 6 Months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Bad Oeynhausen
country: Germany
facility: Herz und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: German Heart Institute Berlin
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Petach Tikvah
country: Israel
facility: Schneider Children's Medical Center of Israel
city: Rome
country: Italy
facility: Ospedale Bambino Gesù
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszyński Institute of Cardiology
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
city: Riyadh
country: Saudi Arabia
facility: Prince Sultan Cardiac Centre
city: Istanbul
country: Turkey
facility: Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: The Heart Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: Deutsches Herzzentrum München
name: Peter Ewert, MD
role: PRINCIPAL_INVESTIGATOR
References: