Transcatheter Pulmonary Valve Therapy for Pulmonary Regurgitation

Not currently recruiting at 11 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Heart Valves

Disqualifiers: RVOTO, Unfavorable RVOT, Pregnancy, 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: 11

Duration: Implantation and initial monitoring

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of the Harmony™ TPV system, a transcatheter pulmonary valve therapy, for treating severe pulmonary regurgitation, a condition where blood flows backward into the heart's right chamber. The study will confirm the long-term benefits of this valve therapy. Individuals needing surgical placement of a heart valve due to severe backward blood flow and willing to participate might be suitable candidates. As an unphased trial, this study offers patients the opportunity to contribute to important research that could enhance future treatments.

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 pulmonary regurgitation?

Research has shown that the Harmony TPV System is generally safe for patients. Studies have found that this device helps maintain good heart function for up to a year, indicating that the treatment is usually well-tolerated. Earlier research confirmed that patients continued to experience safety with the device over the long term. While any medical treatment may carry risks, current evidence supports the safety of the Harmony TPV System for managing heart valve issues. ^{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 to treating pulmonary regurgitation. Traditional treatments typically involve open-heart surgery to replace or repair the valve, which can be quite invasive and come with longer recovery times. The Harmony TPV System, on the other hand, uses a transcatheter method to deliver the new valve, making it less invasive and potentially reducing recovery time. Researchers are excited about this treatment because it could provide a safer, more efficient option for patients who need valve replacement without the need for major surgery.

What evidence suggests that the Harmony TPV System is effective for pulmonary regurgitation?

Research has shown that the Harmony TPV System, which trial participants will receive, effectively treats pulmonary regurgitation, a condition where the heart's pulmonary valve doesn't close properly. Studies found that over 90% of patients with this implant had little to no valve leakage a year after the procedure. Additionally, no deaths were reported six months after treatment, and most patients experienced improved heart function. Over 3 to 5 years, the valve continued to work well and helped improve patients' quality of life. These results suggest that the Harmony TPV System is a promising option for those needing valve replacement. ^{1 2 6 7 8}

Who Is on the Research Team?

John P Cheatham, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have a serious heart valve problem called pulmonary regurgitation, as shown by certain heart tests.

Subject is willing to consent to participate

I need surgery to replace or repair my pulmonary valve.

Exclusion Criteria

The anatomy or shape of the right ventricular outflow tract (RVOT) is not suitable for anchoring the device.

You are pregnant.

You are expected to live for less than a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Harmony TPV 22 or Harmony mTPV 25 device

Implantation and initial monitoring

1 visit (in-person for implantation)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Regular visits over 10 years

Post-Approval Study

Extended follow-up to confirm long-term functionality of the device

5 additional years

What Are the Treatments Tested in This Trial?

Interventions

• Harmony TPV System

Trial Overview 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.

How Is the Trial Designed?

Group I: Harmony TPV System Experimental Treatment 1 Intervention

Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems

Harmony TPV System is already approved in United States, Japan for the following indications:

Approved in United States as Harmony TPV System for:

• Severe pulmonary valve regurgitation associated with native or surgically repaired right ventricular outflow tract (RVOT)

Approved in Japan as Harmony TPV System for:

• Severe pulmonary valve regurgitation associated with native or surgically repaired right ventricular outflow tract (RVOT)

Who Is Running the Clinical Trial?

Medtronic Heart Valves

Lead Sponsor

Trials

3

Recruited

150+

Published Research Related to This Trial

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]

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]

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 (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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015196

Midterm Outcomes in a Pooled Cohort of Harmony ... The Harmony transcatheter pulmonary valve relieves pulmonary regurgitation in patients with a native or surgically repaired right ventricular ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37278682/

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.

3. 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.

4. scai.org scai.org/one-year-outcomes-expanded-cohort-harmony-transcatheter-pulmonary-valve-recipients-coverage-scai

One-Year Outcomes in an Expanded Cohort of Harmony ... 6 month data revealed no mortality and 87.5% freedom from transcatheter pulmonary valve dysfunction. Over 90% of implanted valves had none/trace paravalvular ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40665900/

Midterm Outcomes in a Pooled Cohort of Harmony ... At 3 to 5 years, Harmony TPV replacement resulted in sustained valve competence, beneficial cardiac remodeling, and improved quality of life.

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 ...

7. 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 ...

8. 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.