Pulmonic Valve REplacement Multi-discIpline EMEA Registry

Pulmonary Regurgitation Clinical Trial

— PREMIER  

Official title:

Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356108
• Other study ID #: 2010-11
• Status: Completed
• Start date: January 2011
• Est. completion date: December 19, 2017

Study information

• Verified date: November 2018
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 19, 2017
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Insufficiency
• Pulmonary Regurgitation
• Pulmonary Stenosis
• Pulmonary Valve Insufficiency
• Pulmonary Valve Stenosis
• Respiratory Insufficiency

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Germany	Herz und Diabeteszentrum NRW	Bad Oeynhausen
Germany	German Heart Institute Berlin	Berlin
Germany	Deutsches Herzzentrum München	München
Germany	Universitätsklinikum Münster	Münster
Ireland	Mater Misericordiae University Hospital	Dublin
Israel	Schneider Children's Medical Center of Israel	Petach Tikvah
Italy	Ospedale Bambino Gesù	Rome
Italy	Policlinico San Donato	San Donato Milanese
Poland	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw
Saudi Arabia	King Faisal Specialist Hospital & Research Centre	Riyadh
Saudi Arabia	Prince Sultan Cardiac Centre	Riyadh
Turkey	Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery	Istanbul
United Kingdom	Royal Brompton Hospital	London
United Kingdom	The Heart Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Belgium,  Germany,  Ireland,  Israel,  Italy,  Poland,  Saudi Arabia,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Procedure/Device Success and Freedom from device or procedure related death	6 months
Secondary	Safety and Effectiveness	Freedom from device or procedure related SAE and functional improvement	6 Months