Status:
RECRUITING
PARADIGM: Amplatzer Valvular Plug for PVL Closure
Lead Sponsor:
Abbott Medical Devices
Conditions:
Paravalvular Aortic Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 PV...
Detailed Description
PARADIGM is a prospective, international, multi-center, single arm study to demonstrate the safety and effectiveness of the AVP III for percutaneous, transcatheter closure of paravalvular leak (PVL) o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04489823
Start Date
December 1 2020
End Date
June 30 2026
Last Update
July 11 2025
Active Locations (29)
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1
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35249
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
3
St. Vincent Hospital
Indianapolis, Indiana, United States, 46240
4
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121