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Active, not recruiting Not applicable Interventional

PARADIGM: Amplatzer Valvular Plug for PVL Closure

ClinicalTrials.gov ID: NCT04489823

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 10:54 AM EDT

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

Study identification

NCT ID
NCT04489823
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Abbott Medical Devices
Industry
Enrollment
200 participants

Conditions and interventions

Interventions

  • AVP III Device

Device

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
Nov 30, 2020
Primary completion
Nov 19, 2025
Completion
Dec 12, 2026
Last update posted
Feb 9, 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 9, 2026 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04489823 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →