Pulmonic Valve REplacement Multi-discIpline EMEA Registry (PREMIER)

November 16, 2018 updated by: Edwards Lifesciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

127

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 6 months
Procedure/Device Success and Freedom from device or procedure related death
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Effectiveness
Time Frame: 6 Months
Freedom from device or procedure related SAE and functional improvement
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Peter Ewert, MD, Deutsches Herzzentrum München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

December 19, 2017

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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