Anonymized Data Collection From the CS6BP for Heart Arrythmias Measurements

NCT05723744 | Completed

• 1 other identifier: CL00800
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Arrythmias

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  day 1, procedure day

Study Arms (1)

CS6BP , ECG holter and Blood pressure measurements

EXPERIMENTAL

The investigational device sensors tracings will be compared to the arrhythmia documented in all patients.

Device: ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart Arrythmias

Interventions

ECG Holter and investigational device recordings for the purpose of developing Continuous Measurement of Heart Arrythmias DEVICE

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

CS6BP , ECG holter and Blood pressure measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Interventions

Electrocardiography, Ambulatory

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Aharon Abbo, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label study
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: February 13, 2023
• Study Start: November 27, 2020
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)