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Device
Amplatzer Plug for Aortic Regurgitation (PARADIGM Trial)
N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
PARADIGM Trial 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.Check my eligibility
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.See study design
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.
PARADIGM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a mechanical or biological valve implant in my heart.
Select...
I have a serious heart valve leak causing heart failure or need for regular blood transfusions.
Select...
I am 18 years old or older.
Select...
I have a heart defect that can be fixed with one device.
PARADIGM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Paravalvular leak closure success rate (percent of subjects)
PARADIGM 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.
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
403,988 Total Patients Enrolled
Carlos Ruiz, M.D., Ph.DPrincipal InvestigatorHackensack Meridian Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.My heart valve replacement is significantly loose or malfunctioning.Your heart valve was replaced with a specific type of valve through a procedure.I have an active infection or endocarditis.In the last 6 months, you had a mass, growth, or blood clot in your heart that could cause problems with placing the AVP III.
Research Study Groups:
This trial has the following groups:- Group 1: Paravalvular Leak Closure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there numerous sites in Canada administering this experiment?
"This medical trial is being conducted across 17 different health facilities, with prominent sites such as Henry Ford Hospital in Detroit and Carilion Roanoke Memorial Hospital in Roanoke."
Answered by AI
Is this experiment in a state of recruitment at present?
"According to the details provided on clinicaltrials.gov, this trial has ceased recruiting patients with its last update dating back to June 28th 2022. However, there are presently 22 other medical studies that remain open for enrollment opportunities."
Answered by AI
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