PARADIGM: Amplatzer Valvular Plug for PVL Closure
Public ClinicalTrials.gov record NCT04489823. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04489823
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2020 (Actual)
- Primary completion
- Nov 20, 2025 (Actual)
- Completion
- Dec 13, 2026 (Estimated)
- Last update posted
- Feb 10, 2026
2020 – 2026
United States locations
- U.S. sites
- 14
- U.S. states
- 13
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35249 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Lenox Hill Hospital | New York | New York | 10021 | — |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10021 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | — |
| Intermountain Medical Center | Murray | Utah | 84157 | — |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | — |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04489823, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04489823 live on ClinicalTrials.gov.