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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone | Experimental | Oral Amiodarone 600mg / day, divided into 3 doses (200mg every 8 hours) for 6 days before the procedure and then 400mg / day, divided into 2 doses (200mg every 12 hours) during the 6 days following the implantation of TAVI. |
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| Control | Placebo Comparator | Patients assigned to the control group will receive placebo tablets identical to those of amiodarone. The administration of these tablets will follow the same scheme as in the amiodarone group. Therefore, they will receive placebo tablets orally, 1 tablet every 8 hours 6 days before the procedure and then 1 tablet every 12 hours during the 6 days following the implantation of TAVI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter aortic valve implantation | Procedure | transcatheter aortic valve implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after transcatheter aortic valve implantation (TAVI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Nombela Franco, PhD | Contact | 913303000 | 3283 | luisnombela@yahoo.com |
| Gabriela Tirado-Conte, MD | Contact | 913303000 | 3283 | gabrielatirado@gmail.com |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.
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| 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. | 1-year follow-up |
| Mortality and CV mortality. | Compare all-cause mortality and CV mortality between groups. | 1-year follow-up |
| Number of parients with MACE | MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate. | at 30 days after NOAF |
| Number of parients with MACE | MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate. | at 60 days after NOAF |
| Number of parients with MACE | MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate. | at 6 months after NOAF |
| Number of parients with MACE | MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate. | 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. | 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. | 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. | 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. | 1-year follow-up |
| Incidence of permanent pacemaker implantation in the both groups. | Need of permanent pacemaker implantation in the both groups. | at 30 days after NOAF |
| Incidence of permanent pacemaker implantation in the both groups. | Need of permanent pacemaker implantation in the both groups. | at 60 days after NOAF |
| Incidence of permanent pacemaker implantation in the both groups. | Need of permanent pacemaker implantation in the both groups. | at 6 months after NOAF |
| Incidence of permanent pacemaker implantation in the both groups. | Need of permanent pacemaker implantation in the both groups. | 1-year follow-up |
| Quality of life: EuroQoL 5D | Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1. | at 30 days after NOA |
| Quality of life: Kansas City test | Score between 0 and 100. The best score 100. | at 30 days after NOA |
| Quality of life: EuroQoL 5D | Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1. | at 60 days after NOAF |
| Quality of life: Kansas City test | Score between 0 and 100. The best score 100. | at 60 days after NOAF |
| Quality of life: EuroQoL 5D | Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1. | at 6 months after NOAF |
| Quality of life: Kansas City test | Score between 0 and 100. The best score 100. | at 6 months after NOAF |
| Quality of life: EuroQoL 5D | Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1. | 1-year follow-up |
| Quality of life: Kansas City test | Score between 0 and 100. The best score 100. | 1-year follow-up |
| Readmissions due to CV causes | Compare the number of readmissions due to CV causes | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 1-year follow-up |
| Incidence of Acute renal failure | Compare the number of events due to acute renal failure between groups | baseline |
| Incidence of Acute renal failure | Compare the number of events due to acute renal failure between groups | 30 days after NOA |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |