Pulmonic Valve REplacement Multi-discIpline EMEA Registry (PREMIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356108
Recruitment Status : Active, not recruiting
First Posted : May 19, 2011
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pulmonary Regurgitation Pulmonary Insufficiency Pulmonary Stenosis Device: Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)

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

Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implantation of the SAPIEN™ Transcatheter Heart Valve (THV) in the Pulmonic Position
Actual Study Start Date : January 2011
Actual Primary Completion Date : July 2013
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]
    Procedure/Device Success and Freedom from device or procedure related death

Secondary Outcome Measures :
  1. Safety and Effectiveness [ Time Frame: 6 Months ]
    Freedom from device or procedure related SAE and functional improvement

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356108

University Hospital Leuven
Leuven, Belgium, 3000
Herz und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
German Heart Institute Berlin
Berlin, Germany
Deutsches Herzzentrum München
München, Germany, 80636
Universitätsklinikum Münster
Münster, Germany, 48149
Mater Misericordiae University Hospital
Dublin, Ireland
Schneider Children's Medical Center of Israel
Petach Tikvah, Israel, 49202
Ospedale Bambino Gesù
Rome, Italy, RM 00165
Policlinico San Donato
San Donato Milanese, Italy, 20097
The Cardinal Stefan Wyszyński Institute of Cardiology
Warsaw, Poland, 04-628
Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 11211
Prince Sultan Cardiac Centre
Riyadh, Saudi Arabia, 11625
Mehmet Akif Ersoy Thoracic & Cardiovascular Surgery
Istanbul, Turkey, 34303
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
The Heart Hospital
London, United Kingdom, W1G 8PH
Manchester Royal Infirmary
Manchester, United Kingdom, M139WL
Sponsors and Collaborators
Edwards Lifesciences
Principal Investigator: Peter Ewert, MD Deutsches Herzzentrum München

Responsible Party: Edwards Lifesciences Identifier: NCT01356108     History of Changes
Other Study ID Numbers: 2010-11
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Edwards Lifesciences:

Additional relevant MeSH terms:
Pulmonary Valve Stenosis
Pulmonary Valve Insufficiency
Respiratory Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Respiration Disorders
Respiratory Tract Diseases