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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
transcatheter aortic valve implantation
Incidence of new onset atrial fibrillation
Compare the incidence of new onset atrial fibrillation (NOAF) on patients that receive oral amiodarone versus placebo. NOAF is defined as an irregular rhythm without P wave and irregular ventricular response during at least 30 seconds, detected in the electrocardiographic monitoring during the post-procedural period or in the 60 days ECG Holter in a patient without previous history of atrial fibrillation. NOAF incidence within 30-day after the TAVI procedure is the primary end-point.
Time frame: 30 days after transcatheter aortic valve implantation (TAVI)
Incidence of new onset atrial fibrillation
Compare the incidence of new onset atrial fibrillation (NOAF) on patients that receive oral amiodarone versus placebo. NOAF is defined as an irregular rhythm without P wave and irregular ventricular response during at least 30 seconds, detected in the electrocardiographic monitoring during the post-procedural period or in the 60 days ECG Holter in a patient without previous history of atrial fibrillation. NOAF incidence within 30-day after the TAVI procedure is the primary end-point.
Time frame: 60 days after transcatheter aortic valve implantation (TAVI)
Effect of the amiodarone
Analyze the effect of the amiodarone in the moment of appearance and the burden of AF after TAVI. AF burden, defined as the relative length of the AF registers in relation to the time in sinus rhythm.
Time frame: 1-year follow-up
Mortality and CV mortality.
Compare all-cause mortality and CV mortality between groups.
Time frame: 1-year follow-up
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time frame: at 30 days after NOAF
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time frame: at 60 days after NOAF
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time frame: at 6 months after NOAF
Number of parients with MACE
MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate.
Time frame: 1-year follow-up
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time frame: at 30 days after NOAF
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time frame: at 60 days after NOAF
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time frame: at 6 months after NOAF
Number of adverse events related to amiodarone
The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population.
Time frame: 1-year follow-up
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Time frame: at 30 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Time frame: at 60 days after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Time frame: at 6 months after NOAF
Incidence of permanent pacemaker implantation in the both groups.
Need of permanent pacemaker implantation in the both groups.
Time frame: 1-year follow-up
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time frame: at 30 days after NOA
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Time frame: at 30 days after NOA
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time frame: at 60 days after NOAF
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Time frame: at 60 days after NOAF
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time frame: at 6 months after NOAF
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Time frame: at 6 months after NOAF
Quality of life: EuroQoL 5D
Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1.
Time frame: 1-year follow-up
Quality of life: Kansas City test
Score between 0 and 100. The best score 100.
Time frame: 1-year follow-up
Readmissions due to CV causes
Compare the number of readmissions due to CV causes
Time frame: 1-year follow-up
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time frame: at 30 days after NOA
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time frame: at 60 days after NOAF
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time frame: at 6 months after NOAF
Functional change: New York Heart Association.
Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1.
Time frame: 1-year follow-up
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time frame: at 30 days after NOA
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time frame: at 60 days after NOAF
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time frame: at 6 months after NOAF
Capacity for the exercise
Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups
Time frame: 1-year follow-up
Incidence of Acute renal failure
Compare the number of events due to acute renal failure between groups
Time frame: baseline
Incidence of Acute renal failure
Compare the number of events due to acute renal failure between groups
Time frame: 30 days after NOA
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.