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

Congenital Heart Disease Clinical Trial

Official title:

Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762124
• Other study ID #: 10022972DOC
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: July 2020

Study information

• Verified date: August 2020
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases
• Tetralogy of Fallot

Intervention

Device:
• Native Outflow Tract TPV
Transcatheter placement of a pulmonary valve

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Heart Valves

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Patients with Stent Fracture	The number of patients that experience a stent fracture of their device will be reported.	Through 5 years
Secondary	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
Secondary	Assessment of Surgical Intervention on the TPV	The number of patients that undergo a surgical intervention will be reported.	Through 5 years
Secondary	Number of Patient Deaths (all-cause, procedural, and device-related)	Any patient deaths that occur during the study will be reported.	Through 5 years
Secondary	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
Secondary	Pulmonary Regurgitation Severity as Measured by Echocardiography	The pulmonary regurgitation severity for all patients, as measured by echocardiography, will be reported.	Through 5 years
Secondary	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
Secondary	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