Skip to main content
OpenTrials
Completed

NCT Number: NCT01762124

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Tetralogy of Fallot

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children, Toronto, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Native Outflow Tract TPV

Device

Transcatheter placement of a pulmonary valve

Other names: Native TPV

Primary outcomes

  1. Measurement of radial, linear and axial compression, bending and torsion of device

    Time frame: 4 Days Post-Implant

    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.

Secondary outcomes

  1. Number of Patients with Procedural Success

    Time frame: 24 hours post-implant

    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.

  2. Number of Patients with Serious Procedural Adverse Events

    Time frame: Through 5 year follow-up

    The number of patients that experience a serious procedural adverse event, as defined per the study protocol, will be reported.

  3. Number of Patients with Device-related Adverse Events

    Time frame: Through 5 years

    The number of patients that experience a device-related adverse event, as defined per the study protocol, will be reported.

  4. Number of Patients with Stent Fracture

    Time frame: Through 5 years

    The number of patients that experience a stent fracture of their device will be reported.

  5. Number of Patients with Catheter Re-intervention on the TPV

    Time frame: Through 5 years

    The number of patients that experience a catheter re-intervention will be reported.

  6. Assessment of Surgical Intervention on the TPV

    Time frame: Through 5 years

    The number of patients that undergo a surgical intervention will be reported.

  7. Number of Patient Deaths (all-cause, procedural, and device-related)

    Time frame: Through 5 years

    Any patient deaths that occur during the study will be reported.

  8. Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI

    Time frame: Through 5 years

    The pulmonary regurgitant fraction for all patients, as measured by cardiac MRI, will be reported.

  9. Pulmonary Regurgitation Severity as Measured by Echocardiography

    Time frame: Through 5 years

    The pulmonary regurgitation severity for all patients, as measured by echocardiography, will be reported.

  10. Right Ventricular Volume (ml) as Measured by Cardiac MRI

    Time frame: Through 5 years

    The right ventricular volumes for all patients, as measured by cardiac MRI, will be reported.

  11. Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler

    Time frame: Through 5 years

    The mean RVOT gradient for all patients, as measured by Color Wave Doppler, will be reported.

Sponsors and collaborators

Lead sponsor

Medtronic Heart Valves

Industry

Registry information

Official study title

Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study

Important dates

Study start
2012
Primary completion
2015
Study completion
2020
First posted
Jan 7, 2013
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.