Clinical trial NCT04489823: PARADIGM: Amplatzer Valvular Plug for PVL Closure
Official title: PARADIGM PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paravalvular Aortic Regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PARADIGM is a prospective, international, multi-center, single arm study to demonstrate the safety and effectiveness of the AVP III for percutaneous, transcatheter closure of paravalvular leak (PVL) occurring after aortic or mitral valve replacement with a surgically-implanted mechanical or bioprosthetic valve. The study will be conducted at approximately 25 clinical sites in the US, Europe, and Canada. A total of 200 subjects with a clinically significant PVL will undergo an AVP III implant procedure for PVL closure. Pre-procedural Baseline and follow-up assessments at Discharge, 30 days, 6 months and 1 year will include echocardiography, physical examinations, lab measurements and questionnaires to assess PVL severity, prosthetic valve function, hemolytic anemia, heart failure symptoms, and quality of life. Adverse events will be recorded throughout the study.

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

Primary outcomes:
measure: Paravalvular leak closure success rate (percent of subjects)
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell University
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: Quebec City
country: Canada
facility: Institut de Cardiologie de Quebec (Hôpital Laval)
state: Quebec
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombard
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
state: Silesia
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Edinburgh
country: United Kingdom
facility: Edinburgh Heart Centre
state: Lothian
city: Brighton
country: United Kingdom
facility: The Royal Sussex County Hospital
state: Soeast
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
Study officials:
affiliation: Hackensack Meridian Health
name: Carlos Ruiz, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: