CompletedNot Applicable

Anonymized Data Collection From the CS6BP for Heart Arrythmias Measurements

Israel47 participantsStarted 2020-11-27

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age of eighteen (18) year and above * In clinical need for electrophysiology study (standalone or before ablation procedure) and/or Subjects with AVB who are candidates for pacemaker implantation * Ability and willingness to sign an informed consent form Exclusion Criteria: * Patients with significant co morbidities (assessed by the clinician at screening only): Mechanically ventilated patients Mechanical circulation (LVAD, IABP, ECMO) * Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study * Subjects with PPG SNR \<100 indicated by the CS6BP device * Women who are pregnant or breastfeeding * Subjects with had deformity banning from wearing the device

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Data collection from the CS6BP watch sensors records , ECG holter and Blood pressure device for the purpose of developing Continuous Measurement of Heart Arrythmias

Timeframe: day 1, procedure day

Trial details

NCT IDNCT05723744

SponsorCardiacSense Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-01

View on ClinicalTrials.gov More Heart Arrythmias trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.