Active — Not RecruitingNot Applicable

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

United States86 participantsStarted 2017-01

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

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

Timeframe: 30 days

Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT02979587

SponsorMedtronic Heart Valves

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-17

Results submitted2021-07-16

View on ClinicalTrials.gov More Congenital Heart Disease trials