The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
Study Type
OBSERVATIONAL
Enrollment
346
Oulu University Hospital
Oulu, Finland
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, Germany
Schuechtermann-klinik
Bad Rothenfelde, Germany
Cardiovascular death
Time frame: 30 days post-index procedure
All-cause mortality
Time frame: up to five years
Technical success of implantation
Technical success of implantation, as defined by: * absence of procedural mortality AND * correct positioning of a single prosthetic heart valve into the proper anatomical location AND * no prosthesis - patient mismatch AND * mean aortic valve gradient \<20 mmHg, AND * no moderate or severe prosthetic valve regurgitation
Time frame: day of procedure
Assesment of NYHA classification
Time frame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
Safety profile according to VARC II
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-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 * Prosthetic valve endocarditis * Prosthetic valve thrombosis * Thrombo-embolic events (e.g. stroke) * VARC bleeding, unless clearly unrelated to valve therapy
Time frame: 30 days
In-hospital mortality
Time frame: date of procedure till date of estimated discharge, assessed up to two weeks
Quality of life (EQ5D 5L)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kath. Marienkrankenhaus
Hamburg, Germany
MH Hannover
Hanover, Germany
SLK-Kliniken Heilbronn
Heilbronn, Germany
Ospedale San Raffaele
Milan, Italy
Clinica Mediterranea Neapel
Naples, Italy
Heartcentre Catharina Hospital Eindhoven
Eindhoven, Netherlands
Hospital Universitario La Paz
Madrid, Spain
...and 4 more locations
Time frame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
New pacemaker implantation
Time frame: up to five years
assessment of mean aortic gradient post-implantation
Time frame: up to five years