Clinical trial NCT02979587: The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
Official title: The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Tetrology of Fallot
RVOT Anomaly
Pulmonary Regurgitation
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2016-12-01
Enrollment: 86
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 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.

Detailed description: The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States.

The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom From Procedure- or Device-related Mortality at 30 Days.
timeFrame: 30 days
measure: Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)
timeFrame: At exit from catheterization lab/operating room (OR)
measure: Device Success Out to 5 Years
timeFrame: 5 years
measure: Number of Participants With Procedural Success at 30 Days
timeFrame: 30 days
measure: Freedom From TPV Dysfunction Out to 5 Years
timeFrame: 5 years (5 year data has an anticipated reporting date of April 2025)
measure: Assessment of Safety
timeFrame: Ongoing
measure: Characterization of Quality of Life Scores Out to 5 Years
timeFrame: Baseline, 30 Day, 6 Month, 1 Year, 2 Year, 3 Year
measure: Characterization of Right Ventricle Remodeling Following TPV Implant
timeFrame: Baseline, 6 Month
measure: Characterization of Quality of Life Scores Out to 5 Years
timeFrame: 4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2025)
measure: Characterization of Right Ventricle Remodeling Following TPV Implant
timeFrame: 2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2025)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Regan UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
Study officials:
affiliation: Nationwide Children's Hospital
name: John P Cheatham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillespie MJ, Bergersen L, Benson LN, Weng S, Cheatham JP. 5-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. JACC Cardiovasc Interv. 2021 Apr 12;14(7):816-817. doi: 10.1016/j.jcin.2021.01.046. No abstract available.