Transcatheter Pulmonary Valve Therapy for Pulmonary Regurgitation

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

86 Participants Needed

Trial Summary

What is the purpose of this trial?

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 transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

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 treatment Harmony TPV System for pulmonary regurgitation?

The Harmony transcatheter pulmonary valve (TPV) has shown positive outcomes in treating severe pulmonary regurgitation, with studies indicating its approval by the U.S. Food and Drug Administration for use in patients with native or surgically repaired right ventricular outflow tracts. Additionally, early studies reported low rates of complications like ventricular tachycardia (a type of fast heart rhythm) in patients. ^{1 2 3 4 5}

How is the Harmony TPV treatment different from other treatments for pulmonary regurgitation?

The Harmony TPV is unique because it is the first FDA-approved device specifically designed for severe pulmonary regurgitation in the native or surgically repaired right ventricular outflow tract, offering a minimally invasive option compared to traditional open-heart surgery. ^{1 2 3 4 5}

Research Team

John P Cheatham, MD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

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.

I need surgery to replace or repair my pulmonary valve.

Subject is willing to consent to participate

Exclusion Criteria

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

I had surgery to fix a heart valve issue with an implant.

You are pregnant.

Timeline

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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. 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]

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

Impact of transcatheter pulmonary valve replacement on biventricular strain and synchrony assessed by cardiac magnetic resonance feature tracking. [2022]