Amplatzer Plug for Aortic Regurgitation

(PARADIGM Trial)

Recruiting at 28 trial locations

Overseen By Leslie Centeno

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Medical Devices

Disqualifiers: Rocking valve, Hemodynamic instability, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 1 day

200 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 3 4 5 6}

How 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. ^{1 2 5 7 8}

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.

Research Team

Carlos Ruiz, MD

Principal Investigator

Hackensack Meridian Health

Eligibility 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

Subject has provided written informed consent

I have a mechanical or biological valve implant in my heart.

Note: Subjects in European countries can only be implanted with a mechanical valve in the aortic or mitral position

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an AVP III implant procedure for PVL closure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Visits at Discharge, 30 days, 6 months, and 1 year

Treatment Details

Interventions

• Amplatzer Valvular Plug III

Trial Overview 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.

Participant Groups

Group I: Paravalvular Leak Closure Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Abbott Medical Devices

Lead Sponsor

Trials

659

Recruited

420,000+

Founded

1888

Headquarters

Abbott Park, Illinois, USA

Known For

Medical Devices Innovation

Top Products

FreeStyle Libre, MitraClip, XIENCE Stents, TECNIS IOLs

Dr. Etahn Korngold

Abbott Medical Devices

Chief Medical Officer

Medical training at Harvard Medical School and Massachusetts General Hospital

Robert B. Ford

Abbott Medical Devices

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Findings from Research

An Amplatzer vascular plug II (AVP) was successfully used to occlude an aortic sac in a patient with an infrarenal aortic aneurysm after initial surgical ligation failed, demonstrating its effectiveness in this novel application.

The procedure involved placing the AVP in conjunction with coil embolization of lumbar arteries, and follow-up CT confirmed successful occlusion of the sac, highlighting the AVP's versatility as an embolic device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an Amplatzer vascular plug II for aortic sac occlusion after failed surgical ligation. Tam, MD., Morrow, D., Crawford, MB.[2016]

In an in-vitro study testing Amplatzer devices for closing paravalvular leaks (PVL) after transcatheter aortic valve implantation, the devices showed a maximum efficiency of less than 50% in reducing PVL, indicating limited effectiveness.

The study found that the vascular plugs interfered with the leaflets of the prosthetic valve, suggesting that currently used devices may compromise the valve's structural integrity, highlighting the need for specifically designed occluders for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro hemodynamic testing of Amplatzer plugs for paravalvular leak occlusion after transcatheter aortic valve implantation. Burriesci, G., Peruzzo, P., Susin, FM., et al.[2022]

The Amplatzer Vascular Plug (AVP) was successfully used in a study of six patients to treat vascular complications related to hemodialysis access, achieving 100% technical success in occluding problematic arteriovenous fistulas and grafts.

All patients experienced immediate improvement in distal arterial flow and resolution of clinical symptoms, with no procedure-related complications reported, highlighting the AVP's safety and efficacy as a minimally invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amplatzer vascular plug for arteriovenous hemodialysis access occlusion: initial experience. Bui, JT., Gaba, RC., Knuttinen, MG., et al.[2019]

In a study involving 31 patients, 39 Amplatzer vascular plugs (AVPs) were successfully implanted, achieving a 92% deployment success rate and complete occlusion of the target vessels within 10 minutes, demonstrating their efficacy in treating various congenital cardiovascular malformations.

The use of AVPs was found to be safe, with no procedure-related complications reported, highlighting their reliability as a treatment option for closing medium-to-large vascular communications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amplatzer vascular plugs in congenital cardiovascular malformations. Barwad, P., Ramakrishnan, S., Kothari, SS., et al.[2022]

The Amplatzer Vascular Plug (AVP) is a safe and effective device for occluding peripheral vessels during endovascular abdominal aortic aneurysm repair, with low complication rates such as buttock claudication and endoleaks.

Compared to traditional coil embolization, the AVP not only reduces the risk of complications but also significantly lowers procedural costs, averaging US$310 for the AVP versus US$2262 for coils.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of the Amplatzer Vascular Plug in the prevention of endoleaks during abdominal endovascular aneurysm repair: A systematic literature review on current applications. Bracale, UM., Petrone, A., Provenzano, M., et al.[2022]

In a study of 50 patients with congenital cardiovascular disease, the Amplatzer vascular plugs (plug 1 and plug 2) demonstrated 100% effectiveness in achieving complete occlusion of targeted blood vessels, highlighting their efficacy in vascular occlusion procedures.

The use of these plugs was associated with a low complication rate of only 3.8%, indicating that they are safe for use in a variety of vascular structures, particularly plug 2 for high-flow conditions like type C patent ductus arteriosus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Amplatzer vascular plug and Amplatzer vascular plug II for vascular occlusion procedures in 50 patients with congenital cardiovascular disease. Schwartz, M., Glatz, AC., Rome, JJ., et al.[2012]

The Amplatzer Vascular Plug (AVP) is an effective embolic device for occluding medium to large vessels, but there is a risk of migration, as demonstrated in a case where a 6-mm AVP migrated from the common hepatic artery to the proper hepatic artery during a procedure for pancreatic cancer.

In cases where retrieval of a migrated AVP is not feasible, delivering the device to a less critical artery, such as the splenic artery, can be a viable alternative to achieve complete occlusion, as shown by the successful redeployment of a 10-mm AVP in this case.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter retrieval of an Amplatzer Vascular Plug. Sato, Y., Inaba, Y., Hasegawa, T., et al.[2022]

In a study of seven patients, the Amplatzer vascular II Plug (AVPII) was successfully used for the percutaneous closure of small patent ductus arteriosus, achieving adequate occlusion in 6 out of 7 cases.

The procedure demonstrated safety, with only one major complication reported, and confirmed complete occlusion through echocardiography within 24 hours, indicating the AVPII is an effective option for this type of closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous closure of patent ductus arteriosus using the Amplatzer vascular Plug II]. Parra-Bravo, R., Beirana-Palencia, L., Corona-Rodríguez, A., et al.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of an Amplatzer vascular plug II for aortic sac occlusion after failed surgical ligation. [2016]

2. Netherlands pubmed.ncbi.nlm.nih.gov

In vitro hemodynamic testing of Amplatzer plugs for paravalvular leak occlusion after transcatheter aortic valve implantation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Amplatzer vascular plug for arteriovenous hemodialysis access occlusion: initial experience. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Amplatzer vascular plugs in congenital cardiovascular malformations. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

The Amplatzer vascular plug and Amplatzer vascular plug II for vascular occlusion procedures in 50 patients with congenital cardiovascular disease. [2012]

7. Poland pubmed.ncbi.nlm.nih.gov

Transcatheter retrieval of an Amplatzer Vascular Plug. [2022]

8. Mexico pubmed.ncbi.nlm.nih.gov

[Percutaneous closure of patent ductus arteriosus using the Amplatzer vascular Plug II]. [2011]