Paravalvular Aortic RegurgitationPARADIGMNCT04489823
PARADIGM: Amplatzer Valvular Plug for PVL Closure
A study testing AVP III in people with Paravalvular Aortic Regurgitation, run by Abbott Medical Devices at 24 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paravalvular Aortic Regurgitation
- What is being tested?
- AVP III
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 1 Dec 2020to 13 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States14 sites
Emory University Hospital
Atlanta, Georgia, 30322
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Intermountain Medical Center
Murray, Utah, 84157
Lenox Hill Hospital
New York, New York, 10021
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Providence Sacred Heart Medical Center
Spokane, Washington, 99202
United Kingdom3 sites
The Royal Sussex County Hospital
Brighton, Soeast, BN25BE
Papworth Hospital NHS Foundation Trust
Cambridge
Edinburgh Heart Centre
Edinburgh, Lothian, EH16 4SA
Canada2 sites
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec, Quebec, G1V 4G5
Spain2 sites
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Universitario de Salamanca
Salamanca
Poland1 site
Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
Katowice, Silesian Voivodeship, 40-635
About this study
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
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.
Read the 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 paravalvular leak (PVL) occurring after aortic or mitral valve replacement with a surgically-implanted mechanical or bioprosthetic valve. The study will be conducted at approximately 25 clinical sites in the US, Europe, and Canada. 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.
- Conditions
- Paravalvular Aortic Regurgitation
- Being tested
- AVP III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVP IIIDevice
Transcatheter closure of a paravalvular leak using AVP III
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AVP III |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Dec 2020
- Primary completion20 Nov 2025
- Study completion13 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paravalvular Aortic RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Ruiz, M.D., Ph.D, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489823
- Sponsor's protocol ID
- ABT-CIP-10309
- Acronym
- PARADIGM
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04489823
- Acronym / sponsor ID
- PARADIGM / ABT-CIP-10309
- Conditions
- Paravalvular Aortic Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 paravalvular leak (PVL) occurring after aortic or mitral valve replacement with a surgically-implanted mechanical or bioprosthetic valve. The study will be conducted at approximately 25 clinical sites in the US, Europe, and Canada. 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paravalvular Leak Closure | Experimental | Device: AVP IIIIncludes 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVP IIITranscatheter closure of a paravalvular leak using AVP III | Device | Paravalvular Leak Closure |
Primary outcome
Paravalvular leak closure success rate (percent of subjects)
Time frame: 30 Days
* 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Ruiz, M.D., Ph.D principal investigator
Hackensack Meridian Health
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVP III in people with Paravalvular Aortic Regurgitation, run by Abbott Medical Devices at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, United Kingdom, Canada, Spain, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paravalvular leak closure success rate (percent of subjects) (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.