Research Study: Paradigm
Condition:
heart valve disease
Study Sponsor: Abbott Medical Devices
Study Investigator: Santiago Garcia, MD
Study Contact: Derek Vang
derek.vang@allina.com
612-863-5507
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:

The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the AVP III as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position.
Eligibility Criteria:

Inclusion Criteria:

  • Subject is implanted with a mechanical or biological surgical valve in the aortic or mitral position
  • Note: Subjects in European countries can only be implanted with a mechanical valve in the aortic or mitral position
  • Subject has a clinically significant paravalvular leak with a severity grade of moderate or higher, associated with signs of heart failure and/or hemolysis necessitating recurring blood transfusions.
  • Subject has one clinically significant PVL defect that can be closed with a single AVP III as assessed pre-procedurally
  • Subject has provided written informed consent
  • Subject is ≥18 years old

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!