Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System

A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System

A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).

Inclusion Criteria:

• Patient scheduled for transapical TAVI
• Patient ≥ 70 years of age
• Patient able to give informed written consent
• Patient able to attend follow up examinations

Exclusion Criteria:

• Scheduled concomitant non-TAVI cardiac procedure
• Patient with Left Ventricular Ejection Fraction (LVEF) < 30% at time of enrollment
• Patient with known apical infarcted area
• Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
• Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
• Patient with contra-indications to transapical TAVI
• Patient's inability to tolerate or comply with normal post-surgical drug regimen
• Patient's inability to comply with required follow-ups, including echocardiography
• Patient participation in other clinical trials within previous month