Harmony TPV for Congenital Heart Disease

Not currently recruiting at 20 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve treatment called the Harmony TPV System, designed for individuals with congenital heart disease who require a new pulmonary valve. The trial aims to assess how effectively real-world doctors can use this treatment. Individuals with congenital heart disease needing a pulmonary valve replacement might be suitable candidates. However, those with conditions such as blocked veins or other serious illnesses may not qualify. As an unphased trial, this study provides an opportunity to contribute to understanding the effective use of this treatment in real-world settings.

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 prior data suggests that the Harmony TPV System is safe for congenital heart disease?

Research shows that the Harmony Transcatheter Pulmonary Valve (TPV) System is generally safe for patients. Studies have found that people using this device maintained good heart health and experienced positive outcomes for up to a year. Notably, no deaths related to the procedure or device occurred in the first 30 days after use. These findings suggest that the Harmony TPV is well-tolerated and safe for treating serious heart problems in both children and adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Harmony TPV System is unique because it offers a minimally invasive approach for treating congenital heart disease, specifically targeting issues with the pulmonary valve. Traditional treatments often require open-heart surgery, which can be more invasive and involve longer recovery times. The Harmony TPV System is delivered via a catheter, allowing for the placement of a new valve without the need for major surgery. Researchers are excited about this treatment because it potentially reduces recovery time and the risk of surgical complications, making it a promising option for patients who need a less invasive solution.

What evidence suggests that the Harmony TPV System is effective for congenital heart disease?

Research has shown that the Harmony TPV System, which participants in this trial will receive, holds promise for people with congenital heart disease. Studies found that patients using this device experienced better overall health and improved blood flow through the heart. Key findings include a 98% rate of avoiding major stent fractures and a very low rate of serious blood vessel injury. These results suggest that the Harmony TPV System can effectively improve heart function in people with congenital heart issues. ^{1 2 3 4 6}

Who Is on the Research Team?

David Balzer, MD

Principal Investigator

St. Louis Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

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 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]

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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jcin.2023.03.002

1-Year Outcomes in a Pooled Cohort of Harmony ... The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02979587

The Medtronic Harmony™ Transcatheter Pulmonary Valve ... The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have ...

3. scai.org scai.org/media-center/news-and-articles/first-intermediate-long-term-study-harmony-transcatheter-pulmonary

First Intermediate to Long-Term Study of the Harmony ... The findings show Harmony TPV patients had favorable clinical and hemodynamic outcomes, confirming earlier results and demonstrating continued device safety ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936879823005617

1-Year Outcomes in a Pooled Cohort of Harmony ... The Harmony TPV device demonstrated favorable clinical and hemodynamic outcomes across studies and valve types through 1 year.

5. news.medtronic.com news.medtronic.com/harmony-two-year-outcomes

Medtronic Harmony™ Transcatheter Pulmonary Valve ... Key findings include 0% vascular injury requiring intervention, 98% freedom from major stent fracture (TPV22), and 97% with none/trace or mild ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200046B.pdf

summary of safety and effectiveness data - accessdata.fda.gov The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult patients with severe ...