Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR). (GLUCO-TAVR)
Heart Block, Aortic Stenosis, Bundle-Branch Block
About this trial
This is an interventional prevention trial for Heart Block focused on measuring Transcatheter Aortic Valve Replacement, Glucocorticoids, Inflammation, Conduction disturbances, Heart block
Eligibility Criteria
Inclusion Criteria: Patients eligible for TAVR implantation according to current European Society of Cardiology guidelines: patients with severe symptomatic aortic stenosis that are > 75 years old or have a high surgical risk. Exclusion Criteria: Patients with a prior pacemaker. Patients with contraindications for the use of glucocorticoids including immunosuppression, active or latent infection, documented hypersensitivity or allergy, insulin-dependent diabetes mellitus, glaucoma (both closed-angle and open-angle), recent intestinal perforation, or acute heart failure. Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed). Access for TAVR implantation other than femoral (for example, transapical). Patients on medication that may interact with glucocorticoids.
Sites / Locations
- General University Hospital of AlicanteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention group (Glucocorticoid treatment)
Control group
Saline solution (0.9%)