Atrial Fibrillation New Onset
Conditions
Brief summary
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.
Interventions
PROCEDUREtranscatheter aortic valve implantation
transcatheter aortic valve implantation
Sponsors
Luis Nombela Franco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Phase III Clinical trial, multiple sites, controlled, randomized, double blind, parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women over 18 years old. Women of childbearing age must commit to the use of contraceptive methods of assured efficacy. * Patients that will undergo TAVI due to aortic stenosis. * Sinus rhythm showed by an ECG during 72 hours previous to the inclusion in the study.
Exclusion criteria
* Pregnancy or lactation. Women of childbearing age who do not have a negative pregnancy test. * Paroxysmal persistent or persistent AF (documented record in electrocardiogram or ECG holter) * Congestive heart failure with functional class NYHA IV despite optimal medical treatment. * Sustained hypotension (TAS \< 80mmHg) * Severe mitral stenosis or regurgitation * Treatment with antiarrhythmic drugs (amiodarone included) 3 months before the procedure, treatment with beta-blockers or dihydropyrimidine calcium channel blockers are not considered an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new onset atrial fibrillation | 30 days after transcatheter aortic valve implantation (TAVI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the amiodarone | 1-year follow-up | 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. |
| Mortality and CV mortality. | 1-year follow-up | Compare all-cause mortality and CV mortality between groups. |
| Number of parients with MACE | at 30 days after NOAF | MACE: Stroke, bleeding (major or life-threatening), and all-cause and cardiovascular mortality rate. |
| Number of adverse events related to amiodarone | at 30 days after NOAF | The safety evaluation will be realized by a meticulous vigilance of the adverse effects appeared in the study population. |
| Incidence of permanent pacemaker implantation in the both groups. | at 30 days after NOAF | Need of permanent pacemaker implantation in the both groups. |
| Incidence of new onset atrial fibrillation | 60 days after transcatheter aortic valve implantation (TAVI) | 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. |
| Quality of life: Kansas City test | at 30 days after NOA | Score between 0 and 100. The best score 100. |
| Readmissions due to CV causes | 1-year follow-up | Compare the number of readmissions due to CV causes |
| Functional change: New York Heart Association. | at 30 days after NOA | Evaluate the functional change according to the NYHA scale. Score between 0 and 4. The best score 1. |
| Capacity for the exercise | at 30 days after NOA | Evalue the change in capacity for the exercise, evaluated by the 6-minute walk test between groups |
| Incidence of Acute renal failure | baseline | Compare the number of events due to acute renal failure between groups |
| Quality of life: EuroQoL 5D | at 30 days after NOA | Eq-5D: EuroQoL 5 Dimensions. Score between 0 and 1. The best score 1. |
Contacts
Primary ContactLuis Nombela Franco, PhD
Backup ContactGabriela Tirado-Conte, MD
Outcome results
None listed