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ACTIVE NOT RECRUITING NA

PARADIGM: Amplatzer Valvular Plug for PVL Closure

NCT04489823 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 200 participants
Start Date 2020-12-01
Est. Completion 2026-12-13
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04489823 reports 20 study locations spanning 18 distinct geographic areas — top geographies include New York, Quebec, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04489823?

The interventions under investigation include: AVP III (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04489823?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial