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PARADIGM: Amplatzer Valvular Plug for PVL Closure

NCT04489823 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-02-10

No results posted yet for this 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

  • Paravalvular Aortic Regurgitation

Interventions

DEVICE

AVP III

Transcatheter closure of a paravalvular leak using AVP III

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Carlos Ruiz, M.D., Ph.D · Hackensack Meridian Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-11-20
Completion
2026-12-13
FDA Device
Yes

Countries

  • United States
  • Canada
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04489823 on ClinicalTrials.gov