Congenital Heart Disease Clinical Trial
Official title:
Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
NCT number | NCT01762124 |
Other study ID # | 10022972DOC |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | July 2020 |
Verified date | August 2020 |
Source | Medtronic Cardiovascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Medtronic Heart Valves |
United States, Canada,
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 |
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