Heart ArrythmiasNCT05723744
Anonymized Data Collection From the CS6BP for Heart Arrythmias Measurements
A study testing ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart Arrythmias in people with Heart Arrythmias, run by CardiacSense Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrythmias
- What is being tested?
- ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart Arrythmias
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Nov 2020to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Heart Arrythmias
- Being tested
- ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart Arrythmias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart ArrythmiasDevice
For Candidates for pacemaker implantation: ECG Holter and investigational device recordings (of PPG, ECG, and motion sensors tracings non-invasively) will be recorded before procedure, during patient's hospitalization at cardiology division. Blood pressure values that are collected by an automated cuff will be collected including any notes attached to the values.
All collected data will be analyzed offline
| Study group | Role | What they receive |
|---|---|---|
| CS6BP , ECG holter and Blood pressure measurements | Experimental | The investigational device sensors tracings will be compared to the arrhythmia documented in all patients. Receives: Device: ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart Arrythmias |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection from the CS6BP watch sensors records , ECG holter and Blood pressure device for the purpose of developing Continuous Measurement of Heart Arrythmias
collection of data from the CS6BP sensors simultaneously with ECG Holter and EPS recorded signals to assess heart arrythmias present during EPS.
Measured: day 1, procedure day
Secondary outcomes (1)
Data collection from the CS6BP watch sensors records, ECG holter and blood pressure device for the purpose of developing Continuous Measurement of blood pressure
To collect data simultaneously with the CS6BP watch sensors during EPS in order to characterize different evoked Blood Pressure during the procedures that blood pressure is collected by an automated cuff.
Measured: day 1, procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start27 Nov 2020
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The CS6BP includes a wrist-worn device with a clip connected to the band and is placed over the radial artery or a finger. The device includes a PPG sensor and is connected to ECG cables.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardiacSense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aharon Abbo, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723744
- Sponsor's protocol ID
- CL00800
- Status last verified
- Feb 2023
- First submitted
- 18 Apr 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous Measurement of Heart Arrythmias
- ClinicalTrials.gov ID
- NCT05723744
- Acronym / sponsor ID
- CL00800
- Conditions
- Heart Arrythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- CardiacSense Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The CS6BP includes a wrist-worn device with a clip connected to the band and is placed over the radial artery or a finger. The device includes a PPG sensor and is connected to ECG cables.
| Arm | Type | Receives |
|---|---|---|
| CS6BP , ECG holter and Blood pressure measurements | Experimental | Device: ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart ArrythmiasThe investigational device sensors tracings will be compared to the arrhythmia documented in all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart ArrythmiasFor Candidates for pacemaker implantation: ECG Holter and investigational device recordings (of PPG, ECG, and motion sensors tracings non-invasively) will be recorded before procedure, during patient's hospitalization at cardiology division. Blood pressure values that are collected by an automated cuff will be collected including any notes attached to the values. All collected data will be analyzed offline | Device | CS6BP , ECG holter and Blood pressure measurements |
Primary outcome
Data collection from the CS6BP watch sensors records , ECG holter and Blood pressure device for the purpose of developing Continuous Measurement of Heart Arrythmias
Time frame: day 1, procedure day
collection of data from the CS6BP sensors simultaneously with ECG Holter and EPS recorded signals to assess heart arrythmias present during EPS.
1 secondary outcome
Data collection from the CS6BP watch sensors records, ECG holter and blood pressure device for the purpose of developing Continuous Measurement of blood pressure
Time frame: day 1, procedure day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aharon Abbo, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart Arrythmias in people with Heart Arrythmias, run by CardiacSense Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection from the CS6BP watch sensors records , ECG holter and Blood pressure device for the purpose of developing Continuous Measurement of Heart Arrythmias (time frame: day 1, procedure day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.