Pulmonic Valve REplacement Multi-discIpline EMEA Registry

Brief Title

Pulmonic Valve REplacement Multi-discIpline EMEA Registry

Official Title

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

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 Type

Observational


Primary Outcome

Safety

Secondary Outcome

 Safety and Effectiveness

Condition

Pulmonary Regurgitation

Intervention

Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

127

Start Date

January 2011

Completion Date

December 19, 2017

Primary Completion Date

July 2013

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.
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter Ewert, MD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01356108

Organization ID

2010-11


Responsible Party

Sponsor

Study Sponsor

Edwards Lifesciences


Study Sponsor

Peter Ewert, MD, Principal Investigator, Deutsches Herzzentrum München


Verification Date

November 2018