NCT02979587

Brief Summary

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
57mo left

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
3 countries

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jan 2017Feb 2031

First Submitted

Initial submission to the registry

November 23, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2020

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 2, 2021

Completed
9.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Expected
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

November 23, 2016

Results QC Date

July 16, 2021

Last Update Submit

September 9, 2025

Conditions

Congenital Heart DiseaseTetrology of FallotRVOT AnomalyPulmonary Regurgitation

Outcome Measures

Primary Outcomes (2)

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

    The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.

    30 days

  • Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months

    Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%

    6 months

Secondary Outcomes (9)

  • Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)

    At exit from catheterization lab/operating room (OR)

  • Device Success Out to 5 Years

    5 years

  • Number of Participants With Procedural Success at 30 Days

    30 days

  • Freedom From TPV Dysfunction Out to 5 Years

    5 years (5 year data has an anticipated reporting date of April 2026)

  • Assessment of Safety

    Ongoing

  • +4 more secondary outcomes

Study Arms (1)

Harmony TPV System

OTHER

Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems

Device: Harmony TPV System

Interventions

Harmony TPV SystemDEVICE

The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame. The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience). The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter.

Harmony TPV System

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction \>/= 30%
  • Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
  • Subject is willing to consent to participate

You may not qualify if:

  • Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
  • RVOT anatomy or morphology that is unfavorable for device anchoring
  • Positive pregnancy test
  • Life expectancy of less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Ronald Regan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Related Publications (2)

  • Morray BH, Gillespie MJ, Cheatham JP, Salavitabar A, Peng L, Jones TK, Levi DS, Gray RG, Asnes J, Cabalka AK, Fujimoto K, Qureshi AM, Bergersen L, Benson LN, Haugan D, McElhinney DB. Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients. Circ Cardiovasc Interv. 2025 Sep;18(9):e015196. doi: 10.1161/CIRCINTERVENTIONS.125.015196. Epub 2025 Jul 16.

    PMID: 40665900DERIVED

  • Gillespie MJ, Bergersen L, Benson LN, Weng S, Cheatham JP. 5-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. JACC Cardiovasc Interv. 2021 Apr 12;14(7):816-817. doi: 10.1016/j.jcin.2021.01.046. No abstract available.

    PMID: 33826508DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalTetralogy of FallotPulmonary Valve Insufficiency

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Valve Diseases

Results Point of Contact

Title
Lindsey Gustafson, Clinical Study Manager
Organization
Medtronic
lindsey.m.gustafson@medtronic.com
7635262782

Study Officials

  • John P Cheatham, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

December 1, 2016

Study Start

January 1, 2017

Primary Completion

July 17, 2020

Study Completion (Estimated)

February 1, 2031

Last Updated

September 19, 2025

Results First Posted

December 2, 2021

Record last verified: 2025-09

Locations

US(9)CA(2)JP(1)