PARADIGM: Amplatzer Valvular Plug for PVL Closure

NCT04489823 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10309
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 24

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.

Conditions

Paravalvular Aortic Regurgitation

Outcome Measures

Primary Outcomes (1)

• Paravalvular leak closure success rate (percent of subjects)

  * Successful transcatheter placement in the intended location without interference * Reduction in paravalvular regurgitation severity by ≥ two grades * Freedom from intra-procedural death * Freedom from unplanned transcatheter or surgical re-intervention through 30 days post-implant.

  30 Days

Study Arms (1)

Paravalvular Leak Closure

EXPERIMENTAL

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.

Device: AVP III

Interventions

AVP III DEVICE

Transcatheter closure of a paravalvular leak using AVP III

Paravalvular Leak Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (24)

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

Birmingham, Alabama, 35249, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99202, United States

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T 1C8, Canada

Location

Institut de Cardiologie de Quebec (Hôpital Laval)

Québec, Quebec, G1V 4G5, Canada

Location

Ospedale San Raffaele

Milan, Lombard, 20132, Italy

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Edinburgh Heart Centre

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

The Royal Sussex County Hospital

Brighton, Soeast, BN25BE, United Kingdom

Location

Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Location

Study Officials

• Carlos Ruiz, M.D., Ph.D

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 28, 2020
• Study Start: December 1, 2020
• Primary Completion: November 20, 2025
• Study Completion (Estimated): December 13, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); CA (2); PL (1); ES (2); GB (3); IT (1); US (14)