Clinical trial NCT01762124: Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)
Official title: Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Tetralogy of Fallot
Keywords: Pulmonary valve
Congenital heart disease
Transcatheter pulmonary valve
Percutaneous pulmonary valve
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.

Detailed description: Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device.

Eligibility criteria: Inclusion Criteria:

* Subject has pulmonary regurgitation as per one or more of the following criteria: Severe pulmonary regurgitation as measured by Doppler echocardiography, or Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging
* Clinical indication for surgical placement of a RVOT conduit or bioprosthetic pulmonary valve per one or more of the following criteria: Subject is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the Investigator, or Right ventricular end diastolic volume (RVEDV) ≥ 150 ml/m2
* Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements

Exclusion Criteria:

* Anatomy unable to accommodate a 25 Fr delivery system
* Obstruction of the central veins
* Clinical or biological signs of infection including active endocarditis
* Indicated for intervention of stenosis of the branch pulmonary arteries at time of implant
* Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential
* Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a right ventricle-to-pulmonary artery conduit implant
* 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 Native Outflow Tract TPV in the left heart
* RVOT anatomy or morphology that is unfavorable for anchoring
* Known allergy to aspirin, heparin, or nickel
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
* Pre-existing prosthetic heart valve or prosthetic ring in any position
* Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.

Primary outcomes:
measure: Measurement of radial, linear and axial compression, bending and torsion of device
timeFrame: 4 Days Post-Implant
Secondary outcomes:
measure: Number of Patients with Procedural Success
timeFrame: 24 hours post-implant
measure: Number of Patients with Serious Procedural Adverse Events
timeFrame: Through 5 year follow-up
measure: Number of Patients with Device-related Adverse Events
timeFrame: Through 5 years
measure: Number of Patients with Stent Fracture
timeFrame: Through 5 years
measure: Number of Patients with Catheter Re-intervention on the TPV
timeFrame: Through 5 years
measure: Assessment of Surgical Intervention on the TPV
timeFrame: Through 5 years
measure: Number of Patient Deaths (all-cause, procedural, and device-related)
timeFrame: Through 5 years
measure: Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI
timeFrame: Through 5 years
measure: Pulmonary Regurgitation Severity as Measured by Echocardiography
timeFrame: Through 5 years
measure: Right Ventricular Volume (ml) as Measured by Cardiac MRI
timeFrame: Through 5 years
measure: Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: Lee Benson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital, Columbus, Ohio, USA
name: John P. Cheatham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital, Boston, Massachusetts, USA
name: Lisa Bergersen, MD, MPH
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.
citation: Benson LN, Gillespie MJ, Bergersen L, Cheatham SL, Hor KN, Horlick EM, Weng S, McHenry BT, Osten MD, Powell AJ, Cheatham JP. Three-Year Outcomes From the Harmony Native Outflow Tract Early Feasibility Study. Circ Cardiovasc Interv. 2020 Jan;13(1):e008320. doi: 10.1161/CIRCINTERVENTIONS.119.008320. Epub 2020 Jan 9.