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

• ClinicalTrials.gov Identifier: NCT01762124
• Recruitment Status: Completed
• First Posted: January 7, 2013
• Last Update Posted: August 7, 2020
• Sponsor: Medtronic Heart Valves
• Information provided by (Responsible Party): Medtronic Cardiovascular ( Medtronic Heart Valves )

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.

Condition or disease	Intervention/treatment	Phase
Congenital Heart Disease; Tetralogy of Fallot	Device: Native Outflow Tract TPV	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
• Actual Study Start Date: October 2012
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: July 2020

Arms and Interventions

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 Name: Native TPV

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

United States, Ohio

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Medtronic Heart Valves
• ClinicalTrials.gov Identifier: NCT01762124
• Other Study ID Numbers: 10022972DOC
• First Posted: January 7, 2013
• Last Update Posted: August 7, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Medtronic Cardiovascular ( Medtronic Heart Valves ):

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

Additional relevant MeSH terms:

Heart Diseases; Tetralogy of Fallot; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities