A First in Human Study for the Versa Device for Tricuspid Regurgitation

Transcatheter Tricuspid Repair Utilizing the Versa Vascular Repair System

This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.

Inclusion Criteria:

• Tricuspid regurgitation (TR) associated symptoms despite optimal medical treatment.
• TR ≥ 3 as determined by the assessment of a transthoracic echocardiogram or transesophageal echocardiogram.
• The local multi-disciplinary heart team agrees that the participant is a poor candidate for surgery.
• Age ≥ 18 years at the time of consent.
• Ability and willingness to provide written informed consent prior to any study related procedure(s).

Exclusion Criteria:

• Severe pulmonary hypertension.
• Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mmHg.
• Any condition that would interfere with the Versa procedure, such as prior tricuspid valve repair or tricuspid valve leaflet anatomy which may preclude successful device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of Versa implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle), tricuspid valve anatomy non-evaluable by echocardiography.
• Known allergy to antiplatelet therapy, heparin, or to device materials.
• Femoral venous mass or thrombus or vegetation.
• Tricuspid valve anatomy not compatible with the Versa implant
• Undergone any heart valve surgery within prior 60 days.
• Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 4.0 cm2.
• Severe mitral regurgitation.
• Left Ventricular Ejection Fraction (LVEF) ≤ 20%
• Active endocarditis, other ongoing infection requiring antibiotic therapy.
• Myocardial infarction or percutaneous coronary intervention within prior 30 days.
• Cardiogenic shock or the need for inotropic support or hemodynamic support device (e.g., intra-aortic balloon pump).
• Cerebrovascular Accident (CVA) within prior 30 days
• Active gastrointestinal (GI) bleeding
• Life expectancy of less than 12 months independent of tricuspid valvular disease.
• Subject currently participating in another clinical study (not yet completed primary endpoint).
• Pregnant or nursing subjects or those who plan pregnancy during the study.
• The presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the eye of the investigator, limits the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
• Absence of appropriate venous access.
• Unwillingness to complete the required follow-up visits.