PARADIGM: Amplatzer Valvular Plug for PVL Closure

Paravalvular Aortic Regurgitation Clinical Trial

— PARADIGM  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04489823
• Other study ID #: ABT-CIP-10309
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the 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.

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 PVLs occurring after aortic or mitral valve replacement with a surgically-implanted mechanical or bioprosthetic valve. The study will be conducted at up to 25 clinical sites in the US, EU and Canada, where 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Paravalvular Aortic Regurgitation

Intervention

Device:
• Amplatzer Valvular Plug III
Transcatheter closure of a paravalvular leak using Amplatzer Valvular Plug III

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montréal	Quebec
Canada	Institut de Cardiologie de Quebec (Hôpital Laval)	Quebec
Canada	St. Paul's Hospital	Vancouver
Italy	Ospedale San Raffaele	Milano	Lombard
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
Poland	Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca	Katowice	Silesia
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario de Salamanca	Salamanca
United Kingdom	The Royal Sussex County Hospital	Brighton	Soeast
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge
United Kingdom	Edinburgh Heart Centre	Edinburgh	Lothian
United States	Emory University Hospital	Atlanta	Georgia
United States	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	St. Luke's Hospital	Kansas City	Missouri
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Lenox Hill Hospital	New York	New York
United States	New York Presbyterian Hospital/Cornell University	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Oregon Health & Science University	Portland	Oregon
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Sacred Heart Medical Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paravalvular leak closure success rate (percent of subjects)	Defined as AVPIII placement in the intended location without interference with the prosthetic valve or intraprocedural mortality with at least a 2 severity-grade reduction in paravalvular regurgitation at exit from the procedure and freedom from unplanned AVPIII-related transcatheter or surgical reintervention through 30 days post-implant.	30 Days