PARADIGM: Amplatzer Valvular Plug for PVL Closure

Description

The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (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.

Conditions

Paravalvular Aortic Regurgitation

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Study Overview

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Study Details

Study overview

The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (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.

PARADIGM PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve

PARADIGM: Amplatzer Valvular Plug for PVL Closure

Condition
Paravalvular Aortic Regurgitation
Intervention / Treatment

-

Contacts and Locations

Birmingham

University Hospital - Univ. of Alabama at Birmingham (UAB), Birmingham, Alabama, United States, 35249

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Indianapolis

St. Vincent Hospital, Indianapolis, Indiana, United States, 46240

New Orleans

Ochsner Medical Center, New Orleans, Louisiana, United States, 70121

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Minneapolis

Minneapolis Heart Institute, Minneapolis, Minnesota, United States, 55407

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Kansas City

St. Luke's Hospital, Kansas City, Missouri, United States, 64111

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Carlos Ruiz, M.D., Ph.D, PRINCIPAL_INVESTIGATOR, Hackensack Meridian Health

Study Record Dates

2026-06-30