Early Feasibility Study (EFS) of the Cardiac Implants Percutaneous Ring Annuloplasty System for the Treatment of Functional Tricuspid Regurgitation
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following implantation in patients suffering from ≥ moderate functional tricuspid regurgitation (FTR).
• Moderate to severe functional tricuspid regurgitation (TR) defined by ASE guidelines and the European Association of Echocardiography guidelines.
• Tricuspid valve annular diameter ≥ 40mm or \> 21 mm/m2 as measured by baseline TTE in a 4-chamber view within 90 days prior to index implant procedure.
• Age ≥ 18 years old at the time of enrollment.
• New York Heart Associate Classification ≥ II.
• Symptoms of right heart failure despite optimized medical therapy.
• Multidisciplinary heart team (minimum of four physicians, including imaging, Structural Heart Disease Interventionalist, Heart Failure Cardiologist, and Cardiac Surgeon) agree that percutaneous tricuspid annuloplasty is a reasonable treatment.
• Left Ventricular Ejection Fraction (LVEF) ≥ 30% within 90 days prior to index implant procedure
• The subject has suitable anatomy for investigational device implantation as per imaging requirements.
• The subject has read and signed the informed consent prior to study related procedures.
⁃ The subject is willing and able to comply with all required follow-up evaluations and assessments.