The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis
Segeberger Kliniken, Herzzentrum
Bad Segeberg, Germany
Immanuel Klinik Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Germany
Mitteldeutsches Herzzentrum Universitätsklinikum Halle (Saale)
Halle, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
Mean pressure gradient
Time frame: immediately after index-procedure
30-days survival
Proportion of participants with overall survival at 30 days
Time frame: 30 days
Cardiovascular mortality
Time frame: 30 days
Hemodynamic parameters
pressure gradient, effective orifice area, velocity
Time frame: up to12 months
Technical success of implantation
defined as absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND no severe (\<0.65 cm2/m2) prosthesis - patient mismatch AND mean aortic valve gradient \<20 mmHg AND no moderate or severe prosthetic valve regurgitation
Time frame: immediately after index-procedure
Early safety
all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury stage 2 or 3 (including renal replacement therapy), coronary artery obstruction requiring Intervention, major vascular complication, valve-related dysfunction requiring repeat procedure
Time frame: 30 days
Time related valve safety
structural valve deterioration as defined by * requiring repeat procedure (transcatheter or surgical heart valve replacement) * valve-related dysfunction defined by * mean aortic valve gradient ≥20 mmHg AND * no moderate or severe prosthetic valve regurgitation
Time frame: up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitäres Herzzentrum Hamburg GmbH
Hamburg, Germany
New Pacemaker implantation
Proportion of patients with pacemaker implantations after index-procedure
Time frame: up to 12 months
NYHA classification
Time frame: up to 12 months