Harmony TPV Post-Approval Study

Congenital Heart Disease Clinical Trial

Official title:

Harmony TPV Post-Approval Study (Harmony PAS2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077774
• Other study ID #: MDT20057CON003
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: March 2035

Study information

• Verified date: April 2024
• Source: Medtronic Cardiovascular
• Contact: Michelle Vanney
• Phone: 763-514-4000
• Email: RS.HarmonyPAS2[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2035
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Pulmonary Regurgitation
• Pulmonary Valve Insufficiency
• RVOT Anomaly
• Tetralogy of Fallot
• Tetrology of Fallot

Intervention

Device:
• Harmony TPV System
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham Hospital	Birmingham	Alabama
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Atrium Health Levine Children's Hospital	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Medical City Children's Hospital	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Children's Hospital New York - Presbyterian	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Children's Hospital & Medical Center	Omaha	Nebraska
United States	Phoenix Children's	Phoenix	Arizona
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Saint Louis Children's Hospital	Saint Louis	Missouri
United States	St. Joseph Children's Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:	Mean RVOT gradient as measured by continuous-wave Doppler echocardiography =40 mmHg AND; Pulmonary regurgitant fraction as measured by CMR <20%	6 months
Secondary	Percentage of subjects free from all-cause mortality at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Secondary	Percentage of subjects free from reoperation at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Secondary	Percentage of subjects free from catheter reintervention at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Secondary	Percentage of subjects free from TPV dysfunction at 6-months	Described by Kaplan-Meier statistics at 6-months.	6 months
Secondary	Number and percentage of subjects with procedure success at 30-days		30-days
Secondary	Number and percentage of subjects with serious device-related adverse events at 6 months	Also described with Kaplan-Meier method for AEs of clinical interest.	6 months