Amplatzer Plug for Aortic Regurgitation (PARADIGM Trial)
Recruiting in Palo Alto (17 mi)
+28 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Abbott Medical Devices
Disqualifiers: Rocking valve, Hemodynamic instability, Active infection, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment Amplatzer Valvular Plug III for aortic regurgitation?
The Amplatzer Vascular Plug III has been tested in laboratory settings for its ability to close leaks around heart valves, which suggests it might be effective in treating aortic regurgitation by sealing unwanted openings.
12345Is the Amplatzer Plug safe for use in humans?
The Amplatzer Vascular Plug has been used safely in various procedures, such as preventing leaks during aneurysm repair and treating complications in dialysis access, indicating it is generally safe for human use.
13456How is the Amplatzer Valvular Plug III treatment different from other treatments for aortic regurgitation?
The Amplatzer Valvular Plug III is unique because it is a self-expanding device designed to close leaks around heart valves, offering a minimally invasive option compared to traditional surgery. It is specifically used to address paravalvular leaks (gaps around a valve) and is deployed through a catheter, which is a thin tube inserted into the body, making it less invasive than open-heart surgery.
12578Eligibility Criteria
This trial is for adults over 18 with a mechanical or biological heart valve in the aortic or mitral position and significant paravalvular leak causing heart issues or needing blood transfusions. Not eligible if pregnant, nursing, have limited life expectancy, unstable health, other conflicting conditions, or are in another drug/device study.Inclusion Criteria
I have a mechanical or biological valve implant in my heart.
I have a serious heart valve leak causing heart failure or need for regular blood transfusions.
I am 18 years old or older.
I have a heart defect that can be fixed with one device.
Exclusion Criteria
My veins are not suitable for AVP III delivery.
I have leaking around my artificial heart valves.
I cannot have surgery because my heart and blood circulation are not stable.
My heart's structure makes it unsuitable for a specific closure device due to risk of interference or complications.
I cannot take blood thinners during procedures.
I am capable of understanding and consenting to participate in this trial.
My heart valve replacement is significantly loose or malfunctioning.
I have an active infection or endocarditis.
Participant Groups
The PARADIGM study tests the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) to treat leaks around surgical heart valves. It's a forward-looking single-group study involving multiple centers.
1Treatment groups
Experimental Treatment
Group I: Paravalvular Leak ClosureExperimental Treatment1 Intervention
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.
Amplatzer Valvular Plug III is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Amplatzer Valvular Plug III for:
- Closure of paravalvular leaks (PVLs) following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position
🇺🇸 Approved in United States as Amplatzer Valvular Plug III for:
- Closure of paravalvular leaks (PVLs) following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Lenox Hill HospitalNew York, NY
Institut de Cardiologie de Quebec (Hôpital Laval)Quebec City, Canada
St. Luke's HospitalKansas City, MO
Providence Sacred Heart Medical CenterSpokane, WA
More Trial Locations
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
References
Use of an Amplatzer vascular plug II for aortic sac occlusion after failed surgical ligation. [2016]To present a case of aortic sac occlusion using an Amplatzer vascular plug II (AVP).
In vitro hemodynamic testing of Amplatzer plugs for paravalvular leak occlusion after transcatheter aortic valve implantation. [2022]We aimed to in-vitro test Amplatzer devices (Amplatzer Vascular Plug II and Amplatzer Vascular Plug III, SJM, St. Paul, MN) in closing PVL generated by transcatheter balloon expandable aortic valve prosthesis in order to quantify the effective treatment of PVL.
Amplatzer vascular plug for arteriovenous hemodialysis access occlusion: initial experience. [2019]The Amplatzer Vascular Plug (AVP; AGA Medical, Golden Valley, MN) is a recently developed self-expanding metallic device indicated for peripheral vascular embolizations. Herein, we describe use of this device in the treatment of vascular complications related to arteriovenous hemodialysis fistulas and grafts.
Amplatzer vascular plugs in congenital cardiovascular malformations. [2022]Amplatzer vascular plugs (AVPs) are devices ideally suited to close medium-to-large vascular communications. There is limited published literature regarding the utility of AVPs in congenital cardiovascular malformations (CCVMs).
The use of the Amplatzer Vascular Plug in the prevention of endoleaks during abdominal endovascular aneurysm repair: A systematic literature review on current applications. [2022]The Amplatzer Vascular Plug (AVP) is a vascular occlusion device designed to provide optimal embolization in several fields of the endovascular surgery. A full literature review was conducted to analyze AVPs in comparison with coils for the prevention of endoleaks during endovascular abdominal aortic aneurysm repair.
The Amplatzer vascular plug and Amplatzer vascular plug II for vascular occlusion procedures in 50 patients with congenital cardiovascular disease. [2012]To describe the use of the Amplatzer vascular plug (plug 1) and Amplatzer vascular plug II (plug 2) in patients with congenital cardiovascular disease (CCVD).
Transcatheter retrieval of an Amplatzer Vascular Plug. [2022]An Amplatzer Vascular Plug (AVP), which was designed as a permanent occluding device derived from the Amplatzer Septal Occluder and Amplatzer Duct Occluder, is a useful embolic device that can be precisely deployed in medium to large vessels with high resistance to migration. However, migration of these Amplatzer devices has been reported as a relatively rare but major complication.
[Percutaneous closure of patent ductus arteriosus using the Amplatzer vascular Plug II]. [2011]The Amplatzer vascular II Plug (AVPII) is a self- expanding occluder device, indicated for arterial and venous occlusion in the peripheral circulation.