Harmony TPV Post-Approval Study

Not Applicable

Active, not recruiting

• Conditions: Congenital Heart Disease; Tetrology of Fallot; Pulmonary Regurgitation; RVOT Anomaly

• Registration Number: NCT05077774
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Study Start: 2021-10-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-02
• Primary Completion: 2025-10
• Study Completion: 2035-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
• Patient (or patient's legally authorized representative) is willing to consent to participate in the study

Exclusion Criteria

• Obstruction of the central veins
• Planned concomitant branch pulmonary artery stenting at time of implant
• Subject is pregnant at time of implant procedure
• Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis
• A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
• Planned implantation of the Harmony TPV in the left heart
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
• Pre-existing prosthetic heart valve or prosthetic ring in any position

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:	6 months	* Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND; * Pulmonary regurgitant fraction as measured by CMR \<20%

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects free from catheter reintervention at 6-months	6 months	Described by Kaplan-Meier statistics at 6-months.
Number and percentage of subjects with serious device-related adverse events at 6 months	6 months	Also described with Kaplan-Meier method for AEs of clinical interest.
Percentage of subjects free from all-cause mortality at 6-months	6 months	Described by Kaplan-Meier statistics at 6-months.
Percentage of subjects free from TPV dysfunction at 6-months	6 months	Described by Kaplan-Meier statistics at 6-months.
Number and percentage of subjects with procedure success at 30-days	30-days
Percentage of subjects free from reoperation at 6-months	6 months	Described by Kaplan-Meier statistics at 6-months.

Trial Locations

Locations (20)

University of Alabama at Birmingham Hospital; 🇺🇸 Birmingham, Alabama, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

St. Joseph Children's Hospital; 🇺🇸 Tampa, Florida, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

Saint Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Children's Hospital & Medical Center; 🇺🇸 Omaha, Nebraska, United States

The Mount Sinai Hospital; 🇺🇸 New York, New York, United States

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