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临床试验/NCT04606693
NCT04606693招募中不适用

Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates

Hospital San Carlos, Madrid2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年11月5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
50
试验地点
2
主要终点
Arrhythmic load

研究概览

简要总结

The present prospective cohort study (not randomized) analyses the value of screening and treatment of SAHS in the management of patients with AF refractory to antiarrhythmics drugs, potentially candidates for ablation.

Patients at low risk of suffering from SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit. Patients with high or intermediate risk of SAHS, will undergo respiratory polygraphy. If the result is positive, they will be treated as standard for this syndrome and their heart rate will be monitored for 3 months. After this, the patient's arrhythmic load will be reevaluated differentiating patients into two groups, those that must be ablated from those that have improved their condition and the clinical criteria is no longer ablation but follow-up.

详细描述

All patients who meet all the inclusion criteria and none of the exclusion will have a Stop-Bang questionnaire to define the risk of having a SAHS The assessment of results classifies people at high, intermediate or low risk of SAHS. Low-risk patients will follow conventional management according to the usual criteria of the Arrhythmia Unit.

Patients with high or intermediate-risk will be given a Kardia© recorder and they will be instructed to obtain records of their cardiac rhythm every 5 days (at any time) and whenever the symptoms are suggestived of arrhythmia. This allows estimating arrhythmic load baseline in these patients.

They will also will be given a 7-channel home respiratory polygraphy (with pulse oximetry record, naso-buccal air flow through nasal cannula and thermistor, snoring, thoracoabdominal movements and electrocardiogram). The day after conducting the home polygraphic record, the patient will be evaluated in the Pneumology Outpatient Department, where risk factors, symptoms and Epworth's sleepiness scale will be assessed, the results of the cardiorespiratory polygraphic record, interpreted by Pneumology Service will be given , and based on the above, the diagnosis of SAHS will be determined.

Those patients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.).

During all this time, patients will continue using their rhythm recorders as previously. The overall effect of SAHS treatment on AF recurrences (comparison of arrhythmic load in the previous 3 months with that of the 3 months post-treatment) will be evaluated.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

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

  • Patients with paroxysmal or persistent atrial fibrillation
  • Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic
  • No previous diagnosis of apnea-hypopnea syndrome

排除标准

  • Patients <18 years
  • Pregnant women
  • Doubts about the patient's ability to perform a home respiratory polygraphy
  • Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required)
  • Unavailability for follow-up at our center for at least 1 year.

结局指标

主要结局

Arrhythmic load

时间窗: Six months

Rate of time in FA measured with Kardia © recorder

次要结局

未报告次要终点

研究者

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

Nicasio Perez Castellano

Principal Investigator

Hospital San Carlos, Madrid

研究点 (2)

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