Harmony TPV for Congenital Heart Disease

Recruiting at 19 trial locations

Overseen By Harmony Clinical Study Central Email

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Disqualifiers: Pregnancy, Liver failure, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Harmony TPV treatment for congenital heart disease?

The Harmony transcatheter pulmonary valve (TPV) has shown positive outcomes in treating severe pulmonary regurgitation (a condition where the heart's pulmonary valve doesn't close properly) in patients with repaired heart structures, as it is the first device approved by the U.S. FDA for this purpose. Additionally, a study reported that 95% of patients did not experience significant heart rhythm issues after receiving the Harmony valve. ^{1 2 3 4 5}

Is the Harmony TPV generally safe for humans?

The Harmony TPV has been studied for safety, with early studies showing that it is generally safe, though some patients experienced ventricular tachycardia (a type of fast heart rhythm) in a small percentage of cases. ^{1 2 3 4 6}

How is the Harmony TPV treatment different from other treatments for congenital heart disease?

The Harmony TPV is unique because it is a non-surgical option for replacing the pulmonary valve in patients with congenital heart disease, specifically those with right ventricular outflow tract issues. It is the first FDA-approved device for severe pulmonary regurgitation in these patients, offering a less invasive alternative to traditional surgery. ^{1 2 3 4 7}

What is the purpose of this trial?

The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Research Team

David Balzer, MD

Principal Investigator

St. Louis Children's Hospital

Eligibility Criteria

This trial is for individuals with congenital heart defects who are eligible to receive the Harmony TPV as per current device labeling. Participants must consent to join the study. Exclusions include those with certain anatomical restrictions, central vein obstructions, infections, pregnancy, specific non-cardiac diseases reducing life expectancy under a year, known allergies to aspirin, heparin or nickel, and pre-existing prosthetic heart valves.

Inclusion Criteria

You are able to use the Harmony TPV device according to the instructions in your area.

Patient (or patient's legally authorized representative) is willing to consent to participate in the study

Exclusion Criteria

I am not pregnant, as confirmed by tests before certain procedures.

My central veins are blocked.

I have signs of an infection or active endocarditis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for valve functionality and safety, including hemodynamic function and adverse events

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Harmony TPV System

Trial Overview The study aims to evaluate real-world outcomes of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) implantation in patients with right ventricular outflow tract anomalies due to congenital heart disease. It focuses on how well it works when implanted by various doctors in clinical practice.

Participant Groups

Group I: Harmony TPV System Experimental Treatment 1 Intervention

Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

Findings from Research

In a study involving 20 patients implanted with the Harmony transcatheter pulmonary valve (TPV), 3-year follow-up results showed no deaths and stable valve function in most patients, with only one experiencing mild pulmonary valve regurgitation.

While two patients required a valve-in-valve procedure due to significant neointimal proliferation, the majority of patients had no clinically significant right ventricular outflow tract obstruction or severe complications, indicating the device's overall safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. Benson, LN., Gillespie, MJ., Bergersen, L., et al.[2020]

The Harmony transcatheter pulmonary valve (TPV) showed excellent safety and effectiveness in treating severe pulmonary regurgitation, with 98% of patients free from significant complications after one year.

In a study of 87 patients, there were no deaths, and most patients experienced none or only mild pulmonary regurgitation, indicating strong clinical outcomes for this FDA-approved device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants. Gillespie, MJ., McElhinney, DB., Jones, TK., et al.[2023]

In a study of 30 patients who received the 25 mm Harmony valve for transcatheter pulmonary valve replacement (TPVR), 40% experienced ventricular tachycardia (VT) within the first 24 hours, primarily as nonsustained VT, indicating a significant occurrence of arrhythmias post-implant.

VT events were linked to the positioning of the valve and an increased burden of premature ventricular contractions (PVCs), suggesting that careful valve placement may be crucial in minimizing arrhythmia risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventricular arrhythmias following transcatheter pulmonary valve replacement with the harmony TPV25 device. Taylor, A., Yang, J., Dubin, A., et al.[2022]

The Medtronic Harmony transcatheter pulmonary valve (TPV) shows promise as a non-surgical option for pulmonary valve replacement, with 19 out of 20 implants meeting success criteria in a study involving 66 enrolled patients.

The study highlighted the importance of rigorous anatomical matching for the single-size Harmony TPV, as only 21 out of 270 screened patients were deemed suitable for the implant, indicating a careful selection process to ensure device fit and performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Selection Process for the Harmony Transcatheter Pulmonary Valve Early Feasibility Study. Gillespie, MJ., Benson, LN., Bergersen, L., et al.[2017]

In a study of 17 patients with right ventricular outflow tract dysfunction treated with the Melody transcatheter pulmonary valve, the procedure was successful in all cases, significantly reducing the peak RVOT gradient and showing no significant regurgitation post-implantation.

The study demonstrated the safety of the procedure, with only one major procedural adverse event and no patient deaths, confirming that TPVI with Melody TPV is an effective treatment for patients with repaired congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Following Melody Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract Dysfunction in Repaired Congenital Heart Disease: First Reported Australian Single Centre Experience. Markham, R., Challa, A., Kyranis, S., et al.[2018]

Transcatheter pulmonary valve replacement (TPVR) is a safe and effective procedure for patients weighing less than 20 kg, with a successful valve implantation rate of 84% among 51 reviewed patients.

While TPVR can lead to access site complications, all patients remained alive and showed excellent valve function with minimal pulmonary regurgitation at a median follow-up of 2 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous transcatheter pulmonary valve replacement in children weighing less than 20 kg. Martin, MH., Shahanavaz, S., Peng, LF., et al.[2019]

The Harmony™ Transcatheter Pulmonary Valve has been FDA-approved for replacing pulmonary valves in patients with native right ventricular outflow tracts, marking a significant advancement in cardiac interventions.

This case series demonstrates the successful use of a hybrid approach, combining surgical techniques with transcatheter valve deployment, in two patients with severe pulmonary artery dilation, showcasing a new option for those who still require surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid approach for harmony transcatheter pulmonary valve replacement. Shibbani, K., Aboulhosn, J., Levi, D., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Ventricular arrhythmias following transcatheter pulmonary valve replacement with the harmony TPV25 device. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient Selection Process for the Harmony Transcatheter Pulmonary Valve Early Feasibility Study. [2017]

5. Australia pubmed.ncbi.nlm.nih.gov

Outcomes Following Melody Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract Dysfunction in Repaired Congenital Heart Disease: First Reported Australian Single Centre Experience. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Percutaneous transcatheter pulmonary valve replacement in children weighing less than 20 kg. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Hybrid approach for harmony transcatheter pulmonary valve replacement. [2023]