RECRUITING

PARADIGM: Amplatzer Valvular Plug for PVL Closure

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2020-12-01

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04489823

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Lori Segar

CONTACT

952-221-4053

lori.segar@abbott.com

Leslie Ornelas

CONTACT

480-306-7436

leslie.ornelas@abbott.com

Principal Investigator

Carlos Ruiz, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Study Locations (Sites)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35249

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

St. Vincent Hospital

Indianapolis, Indiana, 46240

United States

Ochsner Medical Center

New Orleans, Louisiana, 70121

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

St. Luke's Hospital

Kansas City, Missouri, 64111

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Lenox Hill Hospital

New York, New York, 10021

United States

New York Presbyterian Hospital/Cornell University

New York, New York, 10021

United States

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Baptist Memorial Hospital

Memphis, Tennessee, 38120

United States

Intermountain Medical Center

Murray, Utah, 84157

United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014

United States

Providence Sacred Heart Medical Center

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

Carlos Ruiz, M.D., Ph.D, PRINCIPAL_INVESTIGATOR, Hackensack Meridian Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2020-12-01

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Paravalvular Aortic Regurgitation