Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation

NCT03477734 | Completed

• 1 other identifier: CL00001
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation. The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG device

Conditions

Atrium; Fibrillation

Outcome Measures

Primary Outcomes (2)

• CardicacSense1 atrial fibrillation detection rate

  Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device.

  24 to 48 hours

• Safety of CardicacSense1

  Incidence and severity of device related Adverse Events

  24 to 48 hours

Secondary Outcomes (1)

• Usability

  24 to 48 hours

Study Arms (2)

CS1 & heart monitor - AF patients

EXPERIMENTAL

Males and females diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed

Device: CS1 & heart monitor

CS1 & heart monitor -Healthy volunteers

ACTIVE COMPARATOR

Males and females not diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed

Device: CS1 & heart monitor

Interventions

CS1 & heart monitor DEVICE

Daily activities while wearing the investigational device as well as the control device

CS1 & heart monitor - AF patients; CS1 & heart monitor -Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of eighteen (18) year and above
• Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems

You may not qualify if:

• 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 low perfusion as indicated by the watch
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (2)

Rambam Medical Center

Haifa, Israel

Location

Sourasky Medical Center

Tel Aviv, 62431, Israel

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ofer Havakuk, MD, PhD

  Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Males and females, 50 of them diagnosed with atrial fibrillation (AF), and 50 healthy participants, at least 30% of each gender in each group.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 26, 2018
• Study Start: February 20, 2019
• Primary Completion: November 25, 2019
• Study Completion: June 9, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)