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The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

NCT02979587 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-09-19

Study results available
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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.

Conditions

  • Congenital Heart Disease
  • Tetrology of Fallot
  • RVOT Anomaly
  • Pulmonary Regurgitation

Interventions

DEVICE

Harmony TPV System

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.

Sponsors & Collaborators

  • Medtronic Heart Valves

    lead INDUSTRY

Principal Investigators

  • John P Cheatham, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-07-17
Completion
2031-02-28
FDA Device
Yes

Countries

  • United States
  • Canada
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02979587 on ClinicalTrials.gov