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NCT04489823 · ClinicalTrials.gov registry record · NA
PARADIGM: Amplatzer Valvular Plug for PVL Closure
A NA study of Paravalvular Aortic Regurgitation, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT04489823: Active NA study of Paravalvular Aortic Regurgitation, sponsored by Abbott Medical Devices.
NCT04489823 is a NA study of Paravalvular Aortic Regurgitation that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04489823, a NA study of Paravalvular Aortic Regurgitation, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
* 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.
Conditions Studied
Interventions
- DEVICE AVP III
Study Locations (20)
New York
- Lenox Hill Hospital - New York
- New York Presbyterian Hospital/Cornell University - New York
Quebec
- Institut de Cardiologie de Montreal (Montreal Heart Inst.) - Montreal
- Institut de Cardiologie de Quebec (Hôpital Laval) - Québec
Alabama
- University Hospital - Univ. of Alabama at Birmingham (UAB) - Birmingham
Georgia
- Emory University Hospital - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Minneapolis Heart Institute - Minneapolis
Missouri
- Saint Luke's Hospital of Kansas City - Kansas City
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2026-12-13 |
| Phase | NA |
What the registry record for NCT04489823 still lists
NCT04489823 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Paravalvular Aortic Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which AVP III is the first listed.
NCT04489823 names 20 study sites across 18 states, led by New York, Quebec, Alabama.
Frequently Asked Questions
What is clinical trial NCT04489823 about?
NCT04489823 is a clinical study titled "PARADIGM: Amplatzer Valvular Plug for PVL Closure". 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 m...
What is the current status of trial NCT04489823?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2020-12-01. Estimated completion is 2026-12-13.
What conditions does trial NCT04489823 study?
This clinical trial studies the following conditions: Paravalvular Aortic Regurgitation.
What interventions are being tested in trial NCT04489823?
The interventions under investigation include: AVP III (DEVICE).
Who is sponsoring clinical trial NCT04489823?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04489823 being conducted?
This trial has 20 study locations across Alabama, Georgia, Massachusetts, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04489823's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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