CTRI/2024/04/065617尚未招募Unknown
A prospective, open label, pilot study to compare ECG electrical signals ofEG 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 - NI
itto Denko Asia Technical Centre Pte Ltd,0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •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
研究者
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