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

NCT01762124 | Completed DMC FDA Device

• 1 other identifier: 10022972DOC
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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.

Conditions

Congenital Heart Disease; Tetralogy of Fallot

Keywords

Pulmonary valve; Congenital heart disease; Transcatheter pulmonary valve; Percutaneous pulmonary valve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of Patients with Procedural Success

  24 hours post-implant

• Number of Patients with Serious Procedural Adverse Events

  Through 5 year follow-up

• Number of Patients with Device-related Adverse Events

  Through 5 years

• Number of Patients with Stent Fracture

  Through 5 years

• Number of Patients with Catheter Re-intervention on the TPV

  Through 5 years

Study Arms (1)

Native Outflow Tract TPV

EXPERIMENTAL

Implantation of the Native Outflow Tract TPV

Device: Native Outflow Tract TPV

Interventions

Native Outflow Tract TPV DEVICE

Transcatheter placement of a pulmonary valve

Also known as: Native TPV

Native Outflow Tract TPV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Heart Valves: lead

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

• Morray BH, Gillespie MJ, Cheatham JP, Salavitabar A, Peng L, Jones TK, Levi DS, Gray RG, Asnes J, Cabalka AK, Fujimoto K, Qureshi AM, Bergersen L, Benson LN, Haugan D, McElhinney DB. Midterm Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Recipients. Circ Cardiovasc Interv. 2025 Sep;18(9):e015196. doi: 10.1161/CIRCINTERVENTIONS.125.015196. Epub 2025 Jul 16.

  PMID: 40665900 DERIVED

• 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.

  PMID: 33826508 DERIVED

• 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.

  PMID: 32525412 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: January 7, 2013
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)