Status:
UNKNOWN
Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).
Lead Sponsor:
Hospital General Universitario de Alicante
Conditions:
Heart Block
Aortic Stenosis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need f...
Detailed Description
Aortic stenosis is the most common valvular heart disease in Europe, and its prevalence is expected to increase in the coming years. The definitive treatment is aortic valve replacement through surger...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06076824
Start Date
August 12 2023
End Date
September 1 2024
Last Update
October 11 2023
Active Locations (1)
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1
General University Hospital of Alicante
Alicante, Spain, 03010