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.
Acute decompensated heart failure requiring hospital admission with 4 weeks of enrollment.
Severe RV dysfunction as assessed by echocardiography.
Primary (organic) tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
Currently participating in another investigational drug or device study.