跳至主要内容
临床试验/CTRI/2024/04/065617
CTRI/2024/04/065617招募中不适用

A prospective, open label, pilot study to compare ECG electrical signals of EG Holter PX3.0 with Bittium Faros 360 (3 channel lead-set with 5 electrodes) ECG Holter to evaluate equivalence via analysis using FDA approved Bittium software without intended use in arrythmia(s) treatment

Nitto Denko Asia Technical Centre Pte Ltd,1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
55
试验地点
1
主要终点
Assess the equivalence of ECG electrical signals of EG Holter PX3.0 with Bittium Faros 360

研究概览

简要总结

Traditional ECG recordings involve placing electrodes on specific locations on the chest, which can be cumbersome and limit patient mobility. Ambulatory ECG monitoring, also known as Holter monitoring, addresses this limitation by allowing for continuous ECG recording over an extended period, typically 24 to 72 hours, allowing the patient to undergo its daily routine activities. This study aims to compare the signal quality and performance of a novel ECG Holter device, the EG Holter PX3.0, against a well-established and FDA-approved device, the Bittium Faros 360. In response to the challenge associated with the conventional ECG monitoring, there is a growing need for alternative monitoring options that address issues of inconvenience and restricted patient activity. If demonstrated to be comparable to current devices, the EG Holter PX3.0 may provide patients undergoing Holter monitoring with a more pleasant and convenient option. Since the EG Holter PX3.0 (assessment of a novel Japanese technology) is a relatively new gadget, it is necessary to assess how well it performs in comparison to the industry standard, the Bittium Faros 360. Data collection as results of this study on analysis can help with future research and development activities connected to the EG Holter PX3.0 and its possible uses in arrhythmia management, even if the study does not intend to use the collected data for arrhythmia diagnosis or treatment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Subjects judged by PI with cardiac arrhythmia(s); Inclusion Criteria based on clinical symptoms 1.Unexplained syncope 2.Recurrent palpitation 3.Mitral valve prolapse with palpitations 4.IHD with severe LV dysfunction 5.Suspected Prinz metal angina 6.COPD patients with palpitations Inclusion criteria on documented arrhythmias 1.Atrial fibrillation (paroxysmal or chronic) 2.Ventricular Tachycardia (sustained or non sustained) 3.Bundle branch block.
  • 4.Supra ventricular Tachycardias including WPW syndrome.
  • 5.Frequent ventricular premature contractions or atrial premature contractions 6.Sinus Bradycardia 7.Sick sinus syndrome 8.First degree or second degree or suspected intermittent third degree atrio ventricular blocks.
  • 9.After initial catheter ablation treatment for atrial fibrillation.
  • 10.Persons with a history of cerebral infarction or transient ischemic attack (TIA) 11.Willing to give written informed consent and adhere to all the requirements of this protocol.

排除标准

  • Subjects with any of the following will be excluded from the participation/enrollment in the clinical trial: 1.As per under use medical device instruction of use.
  • 2.Pregnant and lactating female.
  • 3.Subjects who are chronic smokers and alcoholics 4.Subject having known derma allergy.
  • 5.Any other as adjudicated by PI.

结局指标

主要结局

Assess the equivalence of ECG electrical signals of EG Holter PX3.0 with Bittium Faros 360

时间窗: Baseline to 24 Hours

次要结局

  • Patient experiences; Effect on skin and Ease of use(At 24 Hours; 48 Hours and at 72 Hours)

研究者

发起方
Nitto Denko Asia Technical Centre Pte Ltd,
申办方类型
Other [Medical Device Compnay]
责任方
Principal Investigator
主要研究者

Dr Pradeep Kumar K

Department of Cardiology

研究点 (1)

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