Pulmonic Valve REplacement Multi-discIpline EMEA Registry

Completed

• Conditions: Pulmonary Regurgitation; Pulmonary Stenosis; Pulmonary Insufficiency

• Registration Number: NCT01356108
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Primary Completion: 2013-07
• Study Completion: 2017-12-19
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety	6 months	Procedure/Device Success and Freedom from device or procedure related death

Secondary Outcome Measures

Name	Time	Method
Safety and Effectiveness	6 Months	Freedom from device or procedure related SAE and functional improvement

Trial Locations

Locations (16)

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

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

Prince Sultan Cardiac Centre; 🇸🇦 Riyadh, Saudi Arabia

The Heart Hospital; 🇬🇧 London, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

Ospedale Bambino Gesù; 🇮🇹 Rome, Italy

King Faisal Specialist Hospital & Research Centre; 🇸🇦 Riyadh, Saudi Arabia

Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery; 🇹🇷 Istanbul, Turkey

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikvah, Israel

The Cardinal Stefan Wyszyński Institute of Cardiology; 🇵🇱 Warsaw, Poland

Royal Brompton Hospital; 🇬🇧 London, United Kingdom