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.
Single group
CI Percutaneous Ring Annuloplasty System
DevicePercutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.
Freedom from device or procedure-related mortality
Freedom from mortality determined to be primarily caused by the device or procedure in the primary endpoint cohort. Events adjudicated by a Clinical Events Committee (CEC).
Safety: Incidence of device or procedure-related major adverse events (MAE)
The incidence of MAEs determined to be primarily caused by the device or procedure. Events adjudicated by CEC.
Technical: Proportion of successful access, delivery, and retrieval device delivery system
The proportion of successful access, delivery, and retrieval of the device delivery system.
Technical: Proportion of successful deployment and positioning of the ring implant.
The proportion of successful deployment and correct/stable positioning of the ring implant.
Technical: Freedom from emergency surgery or reintervention
The proportion of subjects free from emergency surgery or reintervention casually related to the device or access procedure.
Freedom from Heart Failure Events
Freedom from heart failure events post-adjustment defined as a heart failure hospitalization, stratified by cardiac related vs. non-cardiac events compared to baseline.
Changes in Heart Failure Biomarkers
Changes in N-terminal (NT)-pro hormone BNP (NT-proBNP) levels as compared to baseline.
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