Obesity Clinical Trial
Official title:
Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study
Approximately one billion people suffer from hypertension worldwide. At least 10% of this
population, that is, 100 million people, also suffers from associated chronic conditions
namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF).
Personal interaction with medical practitioners (doctors) and review of published clinical
research confirms that current non-invasive automatic blood pressure (BP) monitors that rely
on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak
nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP
estimation can lead to wrong diagnoses and hence to complications such as stokes and heart
attacks.
The Sponsor is developing a novel non-invasive BP monitor that is similar to existing
automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in
conjunction with BP pulse data to provide better and more accurate measurements in the above
chronic conditions.
The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP
monitor against invasive BP measurements in a small group of patients who suffer from the
above conditions.
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