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

Primary Purpose

Congenital Heart Disease, Tetralogy of Fallot

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Native Outflow Tract TPV
Sponsored by
Medtronic Heart Valves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Congenital Heart Disease focused on measuring Pulmonary valve, Congenital heart disease, Transcatheter pulmonary valve, Percutaneous pulmonary valve

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's Hospital
  • Nationwide Children's Hospital
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Native Outflow Tract TPV

Arm Description

Implantation of the Native Outflow Tract TPV

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Number of Patients with Stent Fracture
The number of patients that experience a stent fracture of their device will be reported.
Number of Patients with Catheter Re-intervention on the TPV
The number of patients that experience a catheter re-intervention will be reported.
Assessment of Surgical Intervention on the TPV
The number of patients that undergo a surgical intervention will be reported.
Number of Patient Deaths (all-cause, procedural, and device-related)
Any patient deaths that occur during the study will be reported.
Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI
The pulmonary regurgitant fraction for all patients, as measured by cardiac MRI, will be reported.
Pulmonary Regurgitation Severity as Measured by Echocardiography
The pulmonary regurgitation severity for all patients, as measured by echocardiography, will be reported.
Right Ventricular Volume (ml) as Measured by Cardiac MRI
The right ventricular volumes for all patients, as measured by cardiac MRI, will be reported.
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.

Full Information

First Posted
November 30, 2012
Last Updated
August 5, 2020
Sponsor
Medtronic Heart Valves
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1. Study Identification

Unique Protocol Identification Number
NCT01762124
Brief Title
Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)
Official Title
Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Heart Valves

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Tetralogy of Fallot
Keywords
Pulmonary valve, Congenital heart disease, Transcatheter pulmonary valve, Percutaneous pulmonary valve

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Native Outflow Tract TPV
Arm Type
Experimental
Arm Description
Implantation of the Native Outflow Tract TPV
Intervention Type
Device
Intervention Name(s)
Native Outflow Tract TPV
Other Intervention Name(s)
Native TPV
Intervention Description
Transcatheter placement of a pulmonary valve
Primary Outcome Measure Information:
Title
Measurement of radial, linear and axial compression, bending and torsion of device
Description
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.
Time Frame
4 Days Post-Implant
Secondary Outcome Measure Information:
Title
Number of Patients with Procedural Success
Description
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.
Time Frame
24 hours post-implant
Title
Number of Patients with Serious Procedural Adverse Events
Description
The number of patients that experience a serious procedural adverse event, as defined per the study protocol, will be reported.
Time Frame
Through 5 year follow-up
Title
Number of Patients with Device-related Adverse Events
Description
The number of patients that experience a device-related adverse event, as defined per the study protocol, will be reported.
Time Frame
Through 5 years
Title
Number of Patients with Stent Fracture
Description
The number of patients that experience a stent fracture of their device will be reported.
Time Frame
Through 5 years
Title
Number of Patients with Catheter Re-intervention on the TPV
Description
The number of patients that experience a catheter re-intervention will be reported.
Time Frame
Through 5 years
Title
Assessment of Surgical Intervention on the TPV
Description
The number of patients that undergo a surgical intervention will be reported.
Time Frame
Through 5 years
Title
Number of Patient Deaths (all-cause, procedural, and device-related)
Description
Any patient deaths that occur during the study will be reported.
Time Frame
Through 5 years
Title
Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI
Description
The pulmonary regurgitant fraction for all patients, as measured by cardiac MRI, will be reported.
Time Frame
Through 5 years
Title
Pulmonary Regurgitation Severity as Measured by Echocardiography
Description
The pulmonary regurgitation severity for all patients, as measured by echocardiography, will be reported.
Time Frame
Through 5 years
Title
Right Ventricular Volume (ml) as Measured by Cardiac MRI
Description
The right ventricular volumes for all patients, as measured by cardiac MRI, will be reported.
Time Frame
Through 5 years
Title
Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler
Description
The mean RVOT gradient for all patients, as measured by Color Wave Doppler, will be reported.
Time Frame
Through 5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Benson, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John P. Cheatham, MD
Organizational Affiliation
Nationwide Children's Hospital, Columbus, Ohio, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Bergersen, MD, MPH
Organizational Affiliation
Boston Children's Hospital, Boston, Massachusetts, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33826508
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.
Results Reference
derived
PubMed Identifier
32525412
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.
Results Reference
derived

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

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