Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

PARADIGM: Amplatzer Valvular Plug for PVL Closure (PARADIGM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04489823
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2020
Last Update Posted : June 24, 2022
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE July 10, 2020
First Posted Date  ICMJE July 28, 2020
Last Update Posted Date June 24, 2022
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
Paravalvular leak closure success rate (percent of subjects) [ Time Frame: 30 Days ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE PARADIGM: Amplatzer Valvular Plug for PVL Closure
Official Title  ICMJE PARADIGM PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve
Brief 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.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paravalvular Aortic Regurgitation
Intervention  ICMJE Device: Amplatzer Valvular Plug III
Transcatheter closure of a paravalvular leak using Amplatzer Valvular Plug III
Study Arms  ICMJE Experimental: Paravalvular Leak Closure
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.
Intervention: Device: Amplatzer Valvular Plug III
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 1, 2021)
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04489823
Other Study ID Numbers  ICMJE ABT-CIP-10309
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Devices
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos Ruiz, M.D., Ph.D Hackensack Meridian Health
PRS Account Abbott Medical Devices
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP