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Device

Amplatzer Plug for Aortic Regurgitation (PARADIGM Trial)

N/A

Recruiting

Led By Carlos Ruiz, M.D., Ph.D

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is implanted with a mechanical or biological surgical 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

Must not have

Subject has inadequate vasculature for delivery of the AVP III

Subject has a prosthetic aortic valve and prosthetic mitral valve which both have a clinically significant paravalvular leak

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for a heart condition caused by valve surgery. The treatment is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, procedures like PVL closure can generally include risks such as bleeding, infection at the catheter site, allergic reactions to materials used during surgery, and potential damage to surrounding heart structures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have a serious heart valve leak causing heart failure or need for regular blood transfusions.

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I am 18 years old or older.

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I have a heart defect that can be fixed with one device.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My veins are not suitable for AVP III delivery.

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I have leaking around my artificial heart valves.

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I cannot have surgery because my heart and blood circulation are not stable.

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My heart's structure makes it unsuitable for a specific closure device due to risk of interference or complications.

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I cannot take blood thinners during procedures.

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I am capable of understanding and consenting to participate in this trial.

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My heart valve replacement is significantly loose or malfunctioning.

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I have an active infection or endocarditis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Paravalvular leak closure success rate (percent of subjects)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 12Eligibility criteria met