PARADIGM: Amplatzer Valvular Plug for PVL Closure

Launched by ABBOTT MEDICAL DEVICES · Jul 27, 2020

Keywords

ClinConnect Summary

The PARADIGM study is a clinical trial that is investigating a device called the Amplatzer Valvular Plug III (AVP III), which is used to treat a condition known as paravalvular aortic regurgitation. This condition occurs when there is a leak around a heart valve that has been surgically implanted, leading to problems such as heart failure or the need for frequent blood transfusions. The trial aims to show how safe and effective the AVP III is for closing these leaks in patients who have received either a mechanical or biological heart valve in their aortic or mitral positions.

To be eligible for this study, participants must be at least 18 years old and have a significant leak around their heart valve that can be closed with a single AVP III device. They also should have experienced symptoms related to this leak, such as signs of heart failure. However, certain conditions may exclude individuals from participating, such as having an unstable heart condition or an active infection. Those who join the trial can expect to undergo a procedure to place the AVP III and will be monitored for both safety and effectiveness of the treatment. This study is currently recruiting participants, and the researchers are looking for volunteers who meet the criteria to help improve treatment options for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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