None listed
Conditions
Brief summary
While traditional surgical procedures for heart valve replacement generally require a large incision in the middle of the chest and use of a heart-lung machine, the GATE tricuspid valve is delivered through a comparatively small incision in the chest or neck in a beating heart. This approach can be referred to as being “minimally invasive.” The procedure includes use of a catheter delivery system, through which the replacement valve is delivered to the heart. By replacing the diseased native valve, the purpose of the study is to demonstrate that the GATE system provides a safe and effective means of restoring valve function and improving quality of life for patients at high risk for traditional cardiac surgery. The study hypothesizes that replacing the diseased tricuspid valve in a minimally invasive manner will restore valve function, minimize regurgitation (leaking) and lead to improved quality of life.
Interventions
Once an incision in your chest or neck has been made, the valve delivery system is used to guide the replacement valve into your heart. When the valve has been guided to the correct location, it is released from the delivery system. The new valve serves to replace your diseased valve by opening to allow forward flow and closing to prevent leakage.
The duration of the procedure from access to insertion of the replacement of the heart valve is approximately 2 hours, depending of the level of
Once an incision in your chest or neck has been made, the valve delivery system is used to guide the replacement valve into your heart. When the valve has been guided to the correct location, it is released from the delivery system. The new valve serves to replace your diseased valve by opening to allow forward flow and closing to prevent leakage. The duration of the procedure from access to insertion of the replacement of the heart valve is approximately 2 hours, depending of the level of difficulty. The entire procedure is performed while you are under sedation, by a cardiologist supported by a cardiac team. During the procedure, various imaging techniques, e.g., x-ray, doppler echo cardiography, etc., will be used to assure that the replacement heart valve is delivered to its intended implantation site. You will be monitored by a professional team of doctors and nurses in the hospital after the procedure and thereafter during scheduled follow-up visits with your physician. Physical items used include a delivery system and replacement heart valve. Polymers are mainly used to manufacture the delivery system, and the replacement heart valve is mainly manufactured from specially treated tissue that has been securely attached to a self-expanding metal frame. The delivery system, which includes a small tube similar in diameter to the size of a finger, is used to guide and deliver the replacement valve to the heart.
Sponsors
NaviGate Cardiac Structures. Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patient must be 18 years or older at time of consent and must not be a member of a vulnerable population - Patient must provide written informed consent prior to any trial-related procedure. - Patient must agree not to participate in any other clinical trial for a period of one year following the index procedure and be willing to participate in the follow up visits per study outline. - NYHA Functional Class II (conditional), III or IV (ambulatory) - The center's Cardiac Team (Interventional Cardiologist. Cardiac Surgeon and Echo Cardiologist) concur that the percutaneous GATE™ implantation is appropriate for this patient due to the high surgical risk of cardiopulmonary bypass. Echocardiographic Inclusion Criteria: - Moderate or greater than or equal to 3+ TR determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TOE) confirmed by the Image Core Lab - The repeat TTE and TOE must define the anatomy of the TV to be suitable for implantation of the GATE™. - Pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that are not immobile and not fixed to the leaflets. - Left Ventricular Ejection Fraction (LVEF) of greater than or equal to 35% - Right Heart Catheterization: The patient's pulmonary vasculature resistance is less than 5 Woods units - Six Minute Walk Test at Baseline - The patient must walk at least 150 meters
Exclusion criteria
- Patient is currently participating in another clinical trial that has not yet completed its endpoint - Severe uncontrolled hypertension Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) > 110 mmHg - Systolic Pulmonary Artery Pressure >60 mm (determined by right heart cath) - Prior surgical repair or replacement of the tricuspid valve with a bioprosthesis. - Atrial septal defect closure with a device or ventricular septal defect (VSD) repair. - Intracardiac mass, thrombus, or other device other than pacing lead - Mitral Regurgitation (MR) moderate-to-severe or greater than or equal to 3+ Pacemaker or ICD leads that would prevent appropriate placement of the GATE™ atrioventricular valved stent are not mobile and fixed to the leaflet - Active endocarditis (within the Last 90 days). If the patient has a history of endocarditis within one year of the planned procedure, there must be evidence of negative blood cultures, - Myocardial Infarction (MI) or known unstable angina within 30 days prior to procedure - Percutaneous coronary intervention within the last 30 days prior to procedure - Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure, Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. - Hemodynamic instability defined as systolic pressure <90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device - Cerebrovascular Accident (CVA) within prior 6 months prior to enrollment - Chronic Dialysis - Bleeding diatheses or hypercoagulable state - Active peptic ulcer or active gastrointestinal (Gl) bleeding - Contraindication to anticoagulant therapy - Life expectancy of less than 12 months due to non-cardiac conditions - Carcinoid disease and the other primary etiologies of TR to include Ebstein's anomaly, endomyocardial fibrosis, rheumatic heart disease with both stenosis and regurgitation which implies significant subvalvular disease and thickened leaflets not ideal for landing zone - Patient must not be on supplemental oxygen therapy to be a candidate for the study. - Patient is not on dual antiplatelet therapy such that the post op course would require "triple anticoagulant therapy". - Right heart Catheterization: Pulmonary artery resistance of 5 Woods units or more
Outcome results
None listed