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Clinical Trials/NCT01356108
NCT01356108CompletedNot Applicable

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

Edwards Lifesciences16 sites in 9 countries127 target enrollmentStarted: January 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
127
Locations
16
Primary Endpoint
Safety
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Safety

Time Frame: 6 months

Procedure/Device Success and Freedom from device or procedure related death

Secondary Outcomes

  • Safety and Effectiveness(6 Months)

Investigators

Sponsor
Edwards Lifesciences
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (16)

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