Amplatzer Valvular Plug III for Aortic Valve Insufficiency

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Aortic Valve Insufficiency+1 More
Amplatzer Valvular Plug III - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for a heart condition caused by valve surgery. The treatment is safe and effective.

Eligible Conditions
  • Aortic Valve Insufficiency

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 30 Days

30 Days
Paravalvular leak closure success rate (percent of subjects)

Trial Safety

Trial Design

1 Treatment Group

Paravalvular Leak Closure
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Amplatzer Valvular Plug III · No Placebo Group · N/A

Paravalvular Leak Closure
Device
Experimental Group · 1 Intervention: Amplatzer Valvular Plug III · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
599 Previous Clinical Trials
363,180 Total Patients Enrolled
7 Trials studying Aortic Valve Insufficiency
2,091 Patients Enrolled for Aortic Valve Insufficiency
Carlos Ruiz, M.D., Ph.DPrincipal InvestigatorHackensack Meridian Health

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a mechanical or biological valve in the aortic or mitral position.
You have a clinically significant paravalvular leak with a severity grade of moderate or higher, associated with signs of heart failure and/or hemolysis necessitating recurring blood transfusions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.