Research Study: Compassion S3
Condition:
dysfunctional right ventricular outflow tract (RVOT)
Study Sponsor: Edwards Lifesciences
Study Investigator: Santiago Garcia, MD
Study Contact: Sara Olson
Sara.Olson@allina.com
612-873-7601
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

This study will 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.
Eligibility Criteria:

Inclusion Criteria:

  1. Dysfunctional RVOT conduit or previously implanted surgical valve
  2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!