PARADIGM: Amplatzer Valvular Plug for PVL Closure

Overview

About this study

The purpose of this study is 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.

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:

  • 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.

Exclusion Criteria:

  • Subjects < 18 years old.
  • Subject has a rocking valve or extreme dehiscence of the prosthetic valve involving more than 40% of the sewing ring.
  • Subject's PVL(s) originates from a transcatheter aortic or mitral valve replacement, or from rapid deployment or sutureless surgical replacement valves.
  • Subject has a prosthetic aortic valve and prosthetic mitral valve which both have a clinically significant paravalvular leak.
  • Subject who is hemodynamically unstable or who cannot undergo an elective procedure.
  • Subject with active endocarditis or other active infection.
  • Subject has within the last 6 months a previously documented intracardiac mass, vegetation, tumor, or thrombus which would interfere with placement of the AVP III.
  • Subject has inadequate vasculature for delivery of the AVP III.
  • Subject has unsuitable anatomy for PVL closure using the AVP III (such as a PVL associated with an abscess cavity or a pseudoaneurysmal sac) or anatomy where the AVP III would interfere with other intracardiac or intravascular structures (such coronary ostia).
  • Subjects who are unable to receive intraprocedural anticoagulant therapy.
  • Pregnant or nursing subjects or subjects who plan pregnancy during the clinical investigation follow-up period.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Life expectancy is less than 1 year in the opinion of the Investigator.
  • Incapacitated individuals, defined as persons with mental illnesses or handicaps that impair their ability to provide informed consent, or individuals without legal authority to provide informed consent.
  • Individual who are currently participating in an investigational drug or device study that has not reached the primary endpoint or that may confound the results of this study.

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charanjit Rihal, M.D.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available
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CLS-20520181

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