CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 86 enrolled
Drug / intervention
Harmony TPV Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02979587
NCT02979587N/AActive
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The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Medtronic Heart Valves·interventional·Posted Dec 1, 2016·Updated Sep 19, 2025

In Brief

A clinical study evaluating Harmony TPV System for Congenital Heart Disease and 3 related conditions. Active but no longer recruiting, targeting 86 participants across 12 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
CountriesCanada, Japan, United States
Collaborators--

Timeline

N/AActive
201720182019202020212022202320242025202620272028202920302031
First PostedDec 1, 2016
Enrollment StartJan 1, 2017
Primary CompletionJul 17, 2020
Study CompletionFeb 1, 2031
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.6 years ago

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.