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Closure of paravalvular leaks using the Amplatzer Valvular Plug

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

NA · Abbott Medical Devices · NCT04489823

This study is testing a new device called the Amplatzer Valvular Plug to see if it can safely fix leaks around heart valves in people who have had heart surgery.

Quick facts

PhaseNA
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices (industry)
Locations29 sites (Birmingham, Alabama and 28 other locations)
Trial IDNCT04489823 on ClinicalTrials.gov

What this trial studies

The PARADIGM study is a prospective, multicenter, single arm investigation aimed at evaluating the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) for treating clinically significant paravalvular leaks (PVLs) that occur after surgical implantation of mechanical or biological heart valves. Conducted across approximately 25 clinical sites in the US, Europe, and Canada, the study will enroll 200 subjects who will undergo the AVP III implant procedure. Participants will be assessed at multiple time points, including discharge, 30 days, 6 months, and 1 year, to evaluate PVL severity, valve function, and overall quality of life, while monitoring for any adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have a mechanical or biological surgical valve in the aortic or mitral position and a clinically significant PVL requiring intervention.

Not a fit: Patients with a rocking valve, extreme dehiscence of the prosthetic valve, or those whose PVL originates from transcatheter valve replacements may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and health outcomes for patients suffering from paravalvular leaks.

How similar studies have performed: Other studies have shown promise in using similar transcatheter approaches for PVL closure, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion 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

Exclusion Criteria:

* 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 this trial is running

Birmingham, Alabama and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Paravalvular Aortic Regurgitation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.