Atrial Fibrillation New Onset Clinical Trial
Official title:
Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial
New onset atrial fibrillation (NOAF) is a relatively frequent complication after
transcatheter aortic valve implantation (TAVI). This complication has been related with worse
short and long-term outcomes, including higher stroke, mortality, readmission and bleeding
rates. The aim of this study is to evaluate the effectiveness of amiodarone in the prevention
of the NOAF after TAVI.
The study is a multicenter, randomized double-blinded trial including 120 patients without
prior AF that will undergo TAVI in a scheduled basis. Patients will be randomized to be
treated with amiodarone orally from 6 days before to 6 days after the TAVI procedure versus
placebo.
All the patients will be monitored with a 60-day holter to evaluate NOAF incidence. The main
objective is NOAF incidence after TAVI at 30-day. Secondary endpoints are the incidence of
NOAF, stroke, bleeding and all-cause and cardiovascular mortality in both groups at 60-day.
Results of this study can contribute to optimize TAVI results in a short and long term,
potentially improving the survival and quality of life in this group of frail patients with
comorbidities, which makes them vulnerable to NOAF, stroke, bleeding, heart failure and
readmission.
n/a
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