Ensayos clínicos

Inclusion Criteria:

• Age > 18 and ≤ 85 years old.
• Symptomatic severe (Stage D) functional, tricuspid regurgitation (per applicable guidelines).
• Symptomatic despite medical therapy; patient must be on diuretic therapy.
• The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid repair.
• Patient is willing and able to comply with all specified study evaluations and provides written informed consent.

Exclusion Criteria: 

• Echocardiographic/CT parameters (any of the following): 
  • Vessel access or right heart anatomy precluding proper device introduction, deployment and function;
  • LVEF < 30%;
  • Severe right ventricular dysfunction as assessed by the core lab;
  • Patients with systolic pulmonary artery pressure > 60 mmHg.
• Primary tricuspid disease (e.g., rheumatic, myxomatous degeneration, tricuspid valve prolapse, tricuspid stenosis).
• Previous tricuspid leaflet repair or tricuspid valve replacement.
• Presence of two or more trans-tricuspid leads or any single trans-tricuspid lead:
  • Precluding proper placement of or interferes with device;
  • Implanted within the last 180 days;
  • With pacemaker dependency.
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
• Active endocarditis within 90 days of the scheduled implant.
• Significant pericardial effusion.
• Intra-cardiac masses, thrombi or vegetation.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Recurrent (> 2 per 12 months) hospitalizations or ER visit for COPD exacerbation.
• MI or known unstable angina within 30 days prior to the index procedure.
• Any therapeutic invasive cardiac procedure within 30 days prior to the index procedure, or any dual anti-platelet therapy (DAPT) requirement which cannot be interrupted for 7 days.
• Any cardiac surgery, within 3 months prior to procedure.
• Hemodynamic instability or on IV inotropes within 30 days of the scheduled implant.
• Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mm Hg).
• Cerebrovascular Accident (CVA) or TIA within the past 30 days.
• Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 or patient is on chronic dialysis.
• Any physical impairment which limits the patient’s capacity to complete functional testing due to other medical conditions independent of their TR (e.g., orthopedic condition).
• Significant frailty (i.e., Katz Index of Independence in Activities of Daily Living (ADL) ≤ 2) within 90 days of scheduled implant procedure.
• Chronic liver disease with a MELD score of 12 or greater.
• Continuous home oxygen for primary severe COPD.
• Chronic anemia (Hb < 9 g/L) not corrected by transfusion .
• Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3).
• Bleeding disorders or hypercoagulable state.
• Active peptic ulcer or active gastrointestinal (GI) bleeding within 90 days of the scheduled implant .
• Cardiac cachexia.
• Contraindication to anticoagulants or antiplatelet agents.
• Currently or history of IV drug use.
• Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
• Patients in whom transesophageal echocardiography is contraindicated.
• Known allergy to cobalt chromium, nitinol, titanium or contrast agents that cannot be adequately pre-medicated.
• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
• Impaired judgment and/or is undergoing emergent or urgent treatment for tricuspid insufficiency.
• Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
• Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months.
• Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient’s ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.
• Patient is under guardianship.