COMPASSION S3 Post-Approval Study

Overview

About this study

The purpose of this study is to monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve.
RVOT/PV (Pulmonic Valve) with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg.

Exclusion Criteria:

Inability to tolerate an anticoagulation/antiplatelet regimen.
Active bacterial endocarditis or other active infections.

Eligibility last updated 5/13/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Allison Cabalka, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Allison Cabalka, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials