PARADIGM: Amplatzer Valvular Plug for PVL Closure

Running, not enrolling · Not applicable

Conditions studied: Paravalvular Aortic Regurgitation

In brief

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.

Key facts

Study ID

NCT04489823

Run by

Abbott Medical Devices

People needed

200

Starts

2020-12-01

Expected to finish

2026-12-13

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Lenox Hill Hospital — New York, New York, United States
• New York Presbyterian Hospital/Cornell University — New York, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• Intermountain Medical Center — Murray, Utah, United States
• Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States
• Providence Sacred Heart Medical Center — Spokane, Washington, United States
• Institut de Cardiologie de Montreal (Montreal Heart Inst.) — Montreal, Quebec, Canada
• Institut de Cardiologie de Quebec (Hôpital Laval) — Québec, Quebec, Canada
• Ospedale San Raffaele — Milan, Lombard, Italy
• St. Antonius Ziekenhuis — Nieuwegein, Utrecht, Netherlands
• Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca — Katowice, Silesian Voivodeship, Poland
• Hospital Ramón y Cajal — Madrid, Madrid, Spain
• Hospital Universitario de Salamanca — Salamanca, Spain
• Edinburgh Heart Centre — Edinburgh, Lothian, United Kingdom
• The Royal Sussex County Hospital — Brighton, Soeast, United Kingdom
• Papworth Hospital NHS Foundation Trust — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

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