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Transcatheter Pulmonary Valve

Transcatheter Pulmonary Valve Therapy for Pulmonary Regurgitation

N/A

Waitlist Available

Led By John P Cheatham, MD

Research Sponsored by Medtronic Heart Valves

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 year, 5 year (4 & 5 year data has an anticipated reporting date of april 2025)

Awards & highlights

Study Summary

This trial is testing a new system to see if it is safe and effective.

Who is the study for?

This trial is for individuals with severe pulmonary regurgitation, often due to congenital heart defects like Tetralogy of Fallot. Participants need a clinical indication for an RV-PA conduit or bioprosthetic pulmonary valve and must consent to join. It's not suitable for those previously treated with an RV-to-PA conduit implant, have unfavorable RVOT anatomy, are pregnant, or have a life expectancy under one year.Check my eligibility

What is being tested?

The study is evaluating the Harmony TPV System's safety and effectiveness in treating conditions that affect the flow of blood from the right ventricle to the lungs caused by congenital heart issues.See study design

What are the potential side effects?

While specific side effects aren't listed here, similar procedures may include risks such as bleeding, infection at the catheter insertion site, arrhythmias (irregular heartbeats), or damage to blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery to replace or repair my pulmonary valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year, 5 year (2 & 5 year data has an anticipated reporting date of april 2025)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year, 5 year (2 & 5 year data has an anticipated reporting date of april 2025)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year, 5 year (2 & 5 year data has an anticipated reporting date of april 2025) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom From Procedure- or Device-related Mortality at 30 Days.

Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months

Secondary outcome measures

Assessment of Safety

Characterization of Quality of Life Scores Out to 5 Years

Characterization of Right Ventricle Remodeling Following TPV Implant

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Harmony TPV SystemExperimental Treatment1 Intervention

Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medtronic Heart ValvesLead Sponsor

2 Previous Clinical Trials

59 Total Patients Enrolled

John P Cheatham, MDPrincipal InvestigatorNationwide Children's Hospital

Media Library

Harmony TPV System (Transcatheter Pulmonary Valve) Clinical Trial Eligibility Overview. Trial Name: NCT02979587 — N/A

Pulmonary Regurgitation Research Study Groups: Harmony TPV System

Pulmonary Regurgitation Clinical Trial 2023: Harmony TPV System Highlights & Side Effects. Trial Name: NCT02979587 — N/A

Harmony TPV System (Transcatheter Pulmonary Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02979587 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographic areas is this investigation taking place?

"Currently, 11 medical sites are accepting volunteers for this trial. Some of these include Los Angeles, Columbus and Palo Alto - selecting the closest one to you can minimize travel needs if chosen as a participant."

Answered by AI

Has recruitment begun for this clinical experiment?

"This research is no longer searching for participants, according to the clinicaltrials.gov portal; its initial publication was on January 1st 2017 and it last updated on August 23rd 2022. Nonetheless, there are 514 other medical studies currently in search of volunteers."

Answered by AI

Recent research and studies

JACC: Cardiovascular InterventionsJournal

5-year Outcomes from the Harmony Native Outflow Tract Early Feasibility Study

Gillespie, Matthew J., Lisa Bergersen, Lee N. Benson, Shicheng Weng, and John P. Cheatham. 2021. “5-year Outcomes from the Harmony Native Outflow Tract Early Feasibility Study”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2021.01.046.

clinicaltrials.govStudy

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

2017. "The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02979587.

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