Usefulness of Amiodarone for the Prevention of New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 主要终点
- Incidence of new onset atrial fibrillation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 exclusion criteria.
- •Sinus bradycardia (< 50 lpm), PR interval >240 mseg or second or third degree AV block.
- •QT interval longer than 480 msec in an EKG performed in 72 hours before the inclusion, without a permanent pacemaker.
- •Clinical hypo- or hyperthyroidism, clinical or subclinical autoimmune thyroid disease, or multinodular goiter.
- •Allergy or adverse reaction known or suspected to the amiodarone.
- •Denial of the patient or inability to give informed consent.
- •Hypersensitivity to iodo
- •Concomitant drugs that, in association with amiodarone, can induce torsades de pointes
研究组 & 干预措施
Control
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
干预措施: transcatheter aortic valve implantation (Procedure)
Amiodarone
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.
干预措施: transcatheter aortic valve implantation (Procedure)
结局指标
主要结局
Incidence of new onset atrial fibrillation
时间窗: 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.
次要结局
- Incidence of permanent pacemaker implantation in the both groups.(1-year follow-up)
- Number of parients with MACE(1-year follow-up)
- Effect of the amiodarone(1-year follow-up)
- Mortality and CV mortality.(1-year follow-up)
- Quality of life: EuroQoL 5D(1-year follow-up)
- Quality of life: Kansas City test(1-year follow-up)
- Number of adverse events related to amiodarone(1-year follow-up)
- Incidence of Acute renal failure(30 days after NOA)
- Incidence of new onset atrial fibrillation(60 days after transcatheter aortic valve implantation (TAVI))
- Readmissions due to CV causes(1-year follow-up)
- Functional change: New York Heart Association.(1-year follow-up)
- Capacity for the exercise(1-year follow-up)
- Number of parients with MACE(at 30 days after NOAF)
- Number of parients with MACE(at 60 days after NOAF)
- Number of parients with MACE(at 6 months after NOAF)
- Number of adverse events related to amiodarone(at 30 days after NOAF)
- Number of adverse events related to amiodarone(at 60 days after NOAF)
- Number of adverse events related to amiodarone(at 6 months after NOAF)
- Incidence of permanent pacemaker implantation in the both groups.(at 30 days after NOAF)
- Incidence of permanent pacemaker implantation in the both groups.(at 60 days after NOAF)
- Incidence of permanent pacemaker implantation in the both groups.(at 6 months after NOAF)
- Quality of life: EuroQoL 5D(at 30 days after NOA)
- Quality of life: Kansas City test(at 30 days after NOA)
- Quality of life: EuroQoL 5D(at 60 days after NOAF)
- Quality of life: Kansas City test(at 60 days after NOAF)
- Quality of life: EuroQoL 5D(at 6 months after NOAF)
- Quality of life: Kansas City test(at 6 months after NOAF)
- Functional change: New York Heart Association.(at 30 days after NOA)
- Functional change: New York Heart Association.(at 60 days after NOAF)
- Functional change: New York Heart Association.(at 6 months after NOAF)
- Capacity for the exercise(at 30 days after NOA)
- Capacity for the exercise(at 60 days after NOAF)
- Capacity for the exercise(at 6 months after NOAF)
- Incidence of Acute renal failure(baseline)
研究者
Luis Nombela Franco
Principal Investigator
Hospital San Carlos, Madrid