Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia - SLICE LAMRT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Composite primary endpoint
研究概览
简要总结
SLICE-LAMRT is a multicenter, prospective, randomized, double-blind trial that will be carried out in patients older than 18 years with atypical flutter suspected to be of left atrial origin. The aim of this trial is to evaluate the safety and superiority of a substrate-guided ablation procedure vs the conventional strategy guided by electrical activity.
The composite primary endpoint is time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation.
详细描述
Left atrial macroreentrant tachycardias (LAMRT), also known as left atrial flutter, represent a small percentage of supraventricular arrhythmiass. These tachycardias occur due to reentrant circuits, that is, electrical activation that occurs around natural anatomical obstacles or scar areas.
Classically, by analogy with ventricular tachycardias, these tachycardias are approached by delimiting the circuit (locating the anatomical and functional obstacles), searching for critical areas for their maintenance (isthmuses, generally of slow conduction) and creating controlled lesions that interrupt these circuits (catheter ablation). This requires electromagnetic mapping systems and uses programmed stimulation techniques. This approach treats flutter(s) present at the time of ablation to prevent recurrence. However, it is not uncommon for these patients to develop new macroreentrant circuits during the subsequent clinical course, so the recurrence rate of atrial arrhythmias in this population is relatively high.
The goal of this trial is to determine whether substrate-guided ablation of atypical atrial flutter is superior to electrical activation-guided ablation in reducing the recurrence of atrial arrhythmias and increasing the time to first recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia. The investigators hypothesize that ablation not only of inducible tachycardias during the ablation procedure, but guided by the substrate that is most often key to the maintenance of these tachycardias, is superior to conventional treatment in reducing associated clinical events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The double-blind status will be established for the patient and the person responsible for the follow-up and clinical evaluation, who will never know the arm to which the patient has been randomized.
Logically, this randomization will be known to the operator who will carry out the intervention, which will be performed on the basis of two treatment schemes.
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
- •Atypical flutter with positive F wave in V1, suspected left atrial origin.
- •Age ≥ 18 years
- •Capacity to understand the nature of the study, legal ability and willingness to give informed consent.
排除标准
- •Simultaneous participation in a different trial.
- •Presence of congenital heart disease.
- •Suspected flutter of right origin or related to atriotomy scar from previous cardiac surgery.
- •NYHA IV functional class at the time of recruitment.
- •Contraindication to chronic anticoagulation or allergy/intolerance to heparin.
- •Uncontrolled hyperthyroidism.
- •Life expectancy less than 18 months.
- •Presence of heart disease that is expected to require surgery or heart transplantation within 18 months.
- •Pregnancy or the prospect of it in the next 18 months.
- •Left atrium without pathological substrate: area ≥ 4 cm2 of low voltages (<0.5 mV) in the left atrium.
- •Severe fragility (Clinical Frailty Score ≥ 7).
结局指标
主要结局
Composite primary endpoint
时间窗: 18 months
Time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation
次要结局
- Procedure duration(In the procedure)
- Unplanned cardiovascular hospitalisation(18 months)
- Major complications(First month)
- All-cause mortality(18 months)
- Cardiovascular mortality(18 months)
- Proportion of patients without recurrence of atrial arrhythmia at 18 months(18 months)
- Unplanned hospitalization for any cause.(18 months)
研究者
Daniel Rodríguez Muñoz
Principal Investigator
Hospital Universitario 12 de Octubre