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临床试验/NCT03509493
NCT03509493已完成不适用

Detection of the Common Arrhythmia Atrial Fibrillation in Different Patient Target Groups Using the FibriCheck Smartphone Application

Qompium NV8 个研究点 分布在 1 个国家目标入组 465 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
465
试验地点
8
主要终点
Detection of unknown atrial fibrillation

研究概览

简要总结

FibriCheck is a Conformité Européenne (CE)-approved (class IIa) medically diagnostic application that allows for heart rhythm registrations based on an optical signal captured via the smartphone camera. FibriCheck is only available on prescription causing the physician to stay in the 'driving seat' and the application distribution to be traced.

By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:

  • Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
  • Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment

详细描述

Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 50 million people in Europe and the U.S. It is associated with an increasing mortality and risk for transient cerebrovascular incidents and dementia. De novo AF is in most cases asymptomatic and paroxysmal, causing the diagnosis to be made either by chance or in response to an incident. This drastically impacts the quality of life of the patient and is accompanied with a high socio-economic cost. Guidelines indicate that anticoagulation in patients diagnosed with AF is a cost-effective solution for the prevention of strokes.

In addition, depending on the target group, patients identified with AF can receive therapy in order to control the heart rhythm. These procedures (cardioversion and ablation) often result in follow-up consultations that can be avoided if the heart rhythm can be monitored remotely.

By using FibriCheck, a medically validated smartphone application, daily rhythm measurements can be performed using only the smartphone of the patient. This allows for the heart rhythm to be registered and monitored in a home environment and the data to be automatically sent to the physician. This enables the implementation of FibriCheck in two types of scenarios:

  • Scenario 1: the follow-up of patients with high risk parameters for AF development for primary and secondary prevention, whereby detection of AF will result in therapeutic intervention
  • Scenario 2: the realisation of monitoring of the heart rhythm of patients post intervention in a home environment

The follow-up of patients is still driven by the treating physician(s). The objective is to implement a correct and successful process management allowing a smooth implementation of "an application on prescription".

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Group 1: Patients without structural heart disease
  • Age 65 and older
  • CHADSVASc score of 2 or more (including congestive heart failure, hypertension, age, diabetes, previous stroke, vascular disease and sex)
  • Comorbidities such as: coronary artery disease, kidney insufficiency, sleep apnea or symptomatic complaints with negative Holter in the past
  • Group 2: Patients with structural heart disease
  • Age 65 and older
  • CHADSVASc score of 2 or more
  • Left atrial volume indexed for body surface area (BSA) of 34 ml/m² or more, or left atrial diameter > 5 cm
  • And any of the following indicators:
  • Diastolic dysfunction of at least grade 2 with restrictive filling (E/A 2 or more) or disturbed relaxation (E/A 0.8) and with E/e' septal 15 or more (E/e' lateral 10 or more) or tricuspid insufficiency (TI) of 2.8 m/s or more
  • At least mitral insufficiency (grade 2/3 or 3/3) or mitral stenosis
  • Hypertrophic (obstructive) cardiomyopathy
  • Group 3: Patients with high risk parameters for AF development
  • Age 65 or more
  • General Medical Record in the participating practice
  • A 5-year risk of AF of at least 10% according to the CHARGE-AF risk score
  • Group 4: Patients post-cryptogenic stroke or TIA
  • Experienced a cryptogenic TIA or stroke in the past year since the start of the study
  • Group 5: Patients post-cardioversion therapy
  • Confirmed AF patient based on 12-lead ECG
  • Successful AF treatment using cardioversion (DCC or chemical) to convert the heart rhythm back to normal sinus rhythm
  • Subjects are older than 18 years
  • Group 6: Patients post-ablation therapy
  • Confirmed AF patient based on 12-lead ECG
  • Successful AF treatment using ablation therapy to restore the heart rhythm back to sinus rhythm in the past 3 months
  • Subjects are older than 18 years

排除标准

  • Non-native Dutch
  • Pacemaker dependent heart rhythm
  • Perniosis patient
  • Intense callus formation
  • Low adherence to protocol
  • Tremor or Parkinson
  • Signs of Alzheimer or dementia
  • No self-care ability
  • Known AF patient

结局指标

主要结局

Detection of unknown atrial fibrillation

时间窗: 31 December 2017

次要结局

  • Detection of recurrent atrial fibrillation(31 December 2017)

研究者

发起方
Qompium NV
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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