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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 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. The trial reports 20 study locations across 18 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04489823
The ClinicalTrials.gov registry entry for NCT04489823 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 18 distinct geographic areas - top geographies include 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.
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