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PARADIGM: Amplatzer Valvular Plug for PVL Closure (PARADIGM)

Primary Purpose

Paravalvular Aortic Regurgitation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Amplatzer Valvular Plug III
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paravalvular Aortic Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital - Univ. of Alabama at Birmingham (UAB)
  • Emory University Hospital
  • St. Vincent Hospital
  • Ochsner Medical Center
  • Massachusetts General Hospital
  • Henry Ford Hospital
  • Minneapolis Heart Institute
  • Mayo Clinic
  • St. Luke's Hospital
  • University of Nebraska Medical Center
  • Hackensack University Medical Center
  • Lenox Hill Hospital
  • New York Presbyterian Hospital/Cornell University
  • The Cleveland Clinic Foundation
  • Oregon Health & Science University
  • Baptist Memorial Hospital
  • Intermountain Medical Center
  • Carilion Roanoke Memorial Hospital
  • Sacred Heart Medical Center
  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Institut de Cardiologie de Quebec (Hôpital Laval)
  • St. Paul's Hospital
  • Ospedale San Raffaele
  • St. Antonius Ziekenhuis
  • Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
  • Hospital Ramón y Cajal
  • Hospital Universitario de Salamanca
  • Edinburgh Heart Centre
  • The Royal Sussex County Hospital
  • Papworth Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paravalvular Leak Closure

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2020
Last Updated
October 6, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT04489823
Brief Title
PARADIGM: Amplatzer Valvular Plug for PVL Closure
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paravalvular Aortic Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paravalvular Leak Closure
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Amplatzer Valvular Plug III
Intervention Description
Transcatheter closure of a paravalvular leak using Amplatzer Valvular Plug III
Primary Outcome Measure Information:
Title
Paravalvular leak closure success rate (percent of subjects)
Description
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.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Ruiz, M.D., Ph.D
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital - Univ. of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Presbyterian Hospital/Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut de Cardiologie de Quebec (Hôpital Laval)
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
ZIP/Postal Code
V6Z 2E8
Country
Canada
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombard
ZIP/Postal Code
20132
Country
Italy
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
City
Katowice
State/Province
Silesia
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Edinburgh Heart Centre
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
The Royal Sussex County Hospital
City
Brighton
State/Province
Soeast
ZIP/Postal Code
BN25BE
Country
United Kingdom
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PARADIGM: Amplatzer Valvular Plug for PVL Closure

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