Overview

This trial is active, not recruiting.

Conditions congenital heart disease, tetralogy of fallot
Treatment native outflow tract tpv
Sponsor Medtronic Heart Valves
Start date October 2012
End date May 2015
Trial size 20 participants
Trial identifier NCT01762124, 10022972DOC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implantation of the Native Outflow Tract TPV
native outflow tract tpv Native TPV
Transcatheter placement of a pulmonary valve

Primary Outcomes

Measure
Measurement of radial, linear and axial compression, bending and torsion of device
time frame: 4 Days Post-Implant

Secondary Outcomes

Measure
Number of Patients with Procedural Success
time frame: 24 hours post-implant
Number of Patients with Serious Procedural Adverse Events
time frame: Through 5 year follow-up
Number of Patients with Device-related Adverse Events
time frame: Through 5 years
Number of Patients with Stent Fracture
time frame: Through 5 years
Number of Patients with Catheter Re-intervention on the TPV
time frame: Through 5 years
Assessment of Surgical Intervention on the TPV
time frame: Through 5 years
Number of Patient Deaths (all-cause, procedural, and device-related)
time frame: Through 5 years
Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI
time frame: Through 5 years
Pulmonary Regurgitation Severity as Measured by Echocardiography
time frame: Through 5 years
Right Ventricular Volume (ml) as Measured by Cardiac MRI
time frame: Through 5 years
Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler
time frame: Through 5 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
Principal investigator Lee Benson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.