Clinical trial NCT05077774: Harmony TPV Post-Approval Study
Official title: Harmony TPV Post-Approval Study (Harmony PAS2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Tetrology of Fallot
RVOT Anomaly
Pulmonary Regurgitation
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of subjects free from all-cause mortality at 6-months
timeFrame: 6 months
measure: Percentage of subjects free from reoperation at 6-months
timeFrame: 6 months
measure: Percentage of subjects free from catheter reintervention at 6-months
timeFrame: 6 months
measure: Percentage of subjects free from TPV dysfunction at 6-months
timeFrame: 6 months
measure: Number and percentage of subjects with procedure success at 30-days
timeFrame: 30-days
measure: Number and percentage of subjects with serious device-related adverse events at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Tampa
country: United States
facility: St. Joseph Children's Hospital
state: Florida
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis Children's Hospital
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Children's Hospital New York - Presbyterian
state: New York
city: Charlotte
country: United States
facility: Atrium Health Levine Children's Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Medical City Children's Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: St. Louis Children's Hospital
name: David Balzer, MD
role: PRINCIPAL_INVESTIGATOR
References: