Heart Arrythmias Clinical Trial
Official title:
Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous Measurement of Heart Arrythmias
The purpose of this clinical study is to collect data simultaneously with the CS6BP watch sensors during EPS in order to characterize different evoked arrhythmias and record Blood Pressure during the procedures that blood pressure is collected by an automated cuff.
The proposed clinical study is a Prospective Feasibility, Single-Center Study to collect data simultaneously with the CS6BP watch sensors during EPS or during admission in order to characterize different evoked arrhythmias. Subjects will be screened by the principal investigator or PI's delegate for meeting the study inclusion/exclusion criteria. Subjects will be fitted with the CS6BP and ECG Holter by Investigator/Study Coordinator during the preparation of the subject to the procedure; when the subject is anesthetized and fitted with an automatic cuff that is preset to measure BP on a frequency as defined in the procedure protocol. Subjects will be measured simultaneously with CardiacSense device, ECG Holter and EPS recording system if available (- ECG and intracardiac ECG recorded form intra-cardiac catheters). During the EPS the physician will timestamp and mark any provoked arrythmia either on ECG printouts or EPS recording system traces. The device will be removed once patient has recovered. Subjects candidates for pacemaker implantation will be measured simultaneously with CardiacSense device and ECG Holter before procedure, during patient's hospitalization at cardiology division. At the end of the test the CardiacSense device and ECG Holter will be removed and their data will be downloaded. The recorded ECG (from Holter and if available also EPS recording/ mapping system) data will be analyzed by site staff. The analyzed ECG data will be sent to the company with the CS6BP raw data for further investigation. BP values will be collected from subjects that are fitted with an automated cuff for BP monitoring for the purpose of evaluation and if required by the physician, during the hospitalization. All adverse events (whether device related or not) will be reported during the course of the clinical study. All serious adverse events will be reported immediately to the study sponsor and monitor (within one working day). All clinical data will be recorded on appropriate CRFs. ;