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Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation

NCT03477734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-07-21

No results posted yet for this study

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

Interventions

DEVICE

CS1 & heart monitor

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

Sponsors & Collaborators

  • CardiacSense Ltd.

    lead INDUSTRY

Principal Investigators

  • Ofer Havakuk, MD, PhD · Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-11-25
Completion
2020-06-09

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03477734 on ClinicalTrials.gov