PARADIGM - PARAvalvular leak closure with the Amplatzer Valvular Plug occluDer for Interventional transcatheter closure for PVL with surgical bioloGical and Mechanical heart valve

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. 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
2. 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.
3. Subject has one PVL defect that can be closed with a single AVP III as
assessed pre-procedurally
4. Subject has provided written informed consent
5. Subject is >=18 years old

Exclusion Criteria

1. Subject has a rocking valve or extreme dehiscence of the prosthetic valve
involving more than 40% of the sewing ring.
2. Subject*s PVL(s) originates from a transcatheter aortic or mitral valve
replacement, or from rapid deployment or sutureless surgical replacement valves
3. Subject has multiple clinically significant PVL defects adjacent to a single
prosthetic valve, or a prosthetic aortic valve and prosthetic mitral valve
which both have a clinically significant paravalvular leak.
4. Subject who is hemodynamically unstable or who cannot undergo an elective
procedure
5. Subject with known or suspected active endocarditis or other active
infection
6. 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
7. Subject has inadequate vasculature for delivery of the AVP III
8. 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)
9. Subjects who are unable to receive intraprocedural anticoagulant therapy
10. Pregnant or nursing subjects or subjects who plan pregnancy during the
clinical investigation follow-up period.
11. 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.
12. Life expectancy is less than 1 year in the opinion of the Investigator
13. 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.
14. Individuals who are currently participating in an investigational drug or
device study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is a composite of safety and effectiveness measures<br /><br>evaluating the percent of patients successfully treated with an AVP III for the<br /><br>reduction of PVL, where success is defined as:<br /><br>• Transcatheter placement of the AVP III in the intended location without<br /><br>interfering with the surgical valve function on exit from procedure,<br /><br>• Reduction in PVL by greater than or equal to two grades (defined in appendix<br /><br>II of the protocol) on exit from procedure,<br /><br>• Freedom from intra-procedural death, and<br /><br>• Freedom from unplanned surgical procedure or transcatheter reintervention<br /><br>related to the AVP III through 30 days</p><br>

Secondary Outcome Measures