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).
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
38
Cardiapex percutaneous transapical access and closure system
Kerckhoff Clinic
Bad Nauheim, Germany
Hamburg University Heart Center
Hamburg, Germany
Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"
Time frame: Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours
≤30 day apical bleeding requiring surgical intervention
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.