A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made post-procedure, at 30 days and 90 days as well as longer term follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Access, stabilisation and closure of trans-apical approach for TAVI
Access safety
Observation of no myocardial tearing on entry of the device
Time frame: Within 2 hours from initial skin incision
Closure safety
Observation of no acute post-procedural bleeding or pericardial effusion.
Time frame: Within 2 hours from initial skin incision
Investigational device performance: LV function
% LVEF no worse than baseline as assessed by echocardiography
Time frame: 24 hours, 30 days and 90 days post-procedure
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