NCT02987387View on ClinicalTrials.gov

COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction

Active, not recruitingOBSERVATIONAL
Enrollment

57

Participants

Timeline

Start Date

July 17, 2017

Primary Completion Date

August 9, 2021

Study Completion Date

September 30, 2025

Conditions
Pulmonary Valve InsufficiencyPulmonary Valve StenosisHeart Defects, CongenitalCongenital AbnormalitiesCardiovascular DiseasesHeart Diseases
Interventions
DEVICE

SAPIEN XT THV

SAPIEN XT THV will be implanted in the pulmonic position.

Trial Locations (12)

10003

Mount Sinai Beth Israel, New York

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

20010

Children's National Medical Center, Washington D.C.

35294

University of Alabama, Birmingham

43205

Nationwide Children's Hospital, Columbus

44195

Cleveland Clinic Foundation, Cleveland

48201

Children's Hospital of Michigan, Detroit

52242

The University of Iowa, Iowa City

60453

Advocate Children's Hospital, Oak Lawn

80045

Children's Hospital Colorado, Aurora

89109

Children's Heart Center Nevada, Las Vegas

07112

Newark Beth Israel Medical Center, Newark

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY