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临床试验/NCT06291506
NCT06291506招募中不适用

: SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER): a Multicentre Randomized Clinical Trial to Assess Pulmonary Vein Isolation Alone or Combined With Linear Ablation.

Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
176
试验地点
1
主要终点
Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter.

研究概览

简要总结

Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.

Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration >1 week) or long-lasting persistent (continuous AF duración >1 year).
  • One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient.
  • Age >=18 years and written informed consent.

排除标准

  • AF with a reversible cause.
  • Previous pulmonary veins isolation or left atrial linear ablation.
  • Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke <1 month before ablation.
  • Intracranial haemorrhage <3 months before ablation.
  • Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy <1 year.

结局指标

主要结局

Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter.

时间窗: through study completion, 1 year follow-up

Atrial fibrillation, atrial tachycardia (atrial flutter).

次要结局

  • Complications.(through study completion, 1year follow-up)
  • Acute intraprocedure efficacy.(during the ablation procedure and up to 2 months blanking perior)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sergio Castrejón-Castrejón

Consultant of Cardiology, main coinvestigator, coordinator.

Hospital Universitario La Paz

研究点 (1)

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