PARADIGM: Amplatzer Valvular Plug for PVL Closure (PARADIGM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04489823|
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2020
Last Update Posted : May 16, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Paravalvular Aortic Regurgitation||Device: Amplatzer Valvular Plug III||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PARADIGM PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: Paravalvular Leak Closure
Includes all eligible subjects who undergo an AVP III implant attempt for treatment of significant paravalvular leakage with an echocardiographic severity grade of moderate or higher. This is a single arm study.
Device: Amplatzer Valvular Plug III
Transcatheter closure of a paravalvular leak using Amplatzer Valvular Plug III
- Paravalvular leak closure success rate (percent of subjects) [ Time Frame: 30 Days ]Defined as AVPIII placement in the intended location without interference with the prosthetic valve or intraprocedural mortality with at least a 2 severity-grade reduction in paravalvular regurgitation at exit from the procedure and freedom from unplanned AVPIII-related transcatheter or surgical reintervention through 30 days post-implant.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04489823
|Principal Investigator:||Carlos Ruiz, M.D., Ph.D||Hackensack Meridian Health|
|Responsible Party:||Abbott Medical Devices|
|Other Study ID Numbers:||
|First Posted:||July 28, 2020 Key Record Dates|
|Last Update Posted:||May 16, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
Aortic Valve Insufficiency
Aortic Valve Disease
Heart Valve Diseases