Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Tetralogy of Fallot; Congenital Heart Disease
• Intervention / Treatment: Device: Native Outflow Tract TPV

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Native Outflow Tract TPV; Implantation of the Native Outflow Tract TPV	Device: Native Outflow Tract TPV; Transcatheter placement of a pulmonary valve; Other Names: Native TPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of radial, linear and axial compression, bending and torsion of device	The following variables will be measured: radial compression, linear compression, axial compression, device bending and device torsion using the discharge CT. The degree of deformation of the device will be reported.	4 Days Post-Implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients with Procedural Success	The number of patients who are successfully implanted with the device will be reported. This is measured by meeting all of the following criteria: Confirmation that the device is fixated within the desired location, RV-PA peak-to-peak gradient is less than 25 mmHg, Pulmonary regurgitation is moderate or less, and the subject is free of explantation at 24 hours post-implant.	24 hours post-implant
Number of Patients with Serious Procedural Adverse Events	The number of patients that experience a serious procedural adverse event, as defined per the study protocol, will be reported.	Through 5 year follow-up
Number of Patients with Device-related Adverse Events	The number of patients that experience a device-related adverse event, as defined per the study protocol, will be reported.	Through 5 years
Number of Patients with Stent Fracture	The number of patients that experience a stent fracture of their device will be reported.	Through 5 years
Number of Patients with Catheter Re-intervention on the TPV	The number of patients that experience a catheter re-intervention will be reported.	Through 5 years
Assessment of Surgical Intervention on the TPV	The number of patients that undergo a surgical intervention will be reported.	Through 5 years
Number of Patient Deaths (all-cause, procedural, and device-related)	Any patient deaths that occur during the study will be reported.	Through 5 years
Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI	The pulmonary regurgitant fraction for all patients, as measured by cardiac MRI, will be reported.	Through 5 years
Pulmonary Regurgitation Severity as Measured by Echocardiography	The pulmonary regurgitation severity for all patients, as measured by echocardiography, will be reported.	Through 5 years
Right Ventricular Volume (ml) as Measured by Cardiac MRI	The right ventricular volumes for all patients, as measured by cardiac MRI, will be reported.	Through 5 years
Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler	The mean RVOT gradient for all patients, as measured by Color Wave Doppler, will be reported.	Through 5 years

Collaborators and Investigators

• Sponsor: Medtronic Heart Valves
• Investigators: Principal Investigator: Lee Benson, MD, The Hospital for Sick Children, Toronto, Canada; Principal Investigator: John P. Cheatham, MD, Nationwide Children's Hospital, Columbus, Ohio, USA; Principal Investigator: Lisa Bergersen, MD, MPH, Boston Children's Hospital, Boston, Massachusetts, USA

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Congenital heart disease; Pulmonary valve; Transcatheter pulmonary valve; Percutaneous pulmonary valve
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Tetralogy of Fallot; Heart Defects, Congenital
• Other Study ID Numbers: 10022972DOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes