Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
Primary Purpose
Atrium; Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CS1 & heart monitor
Sponsored by
About this trial
This is an interventional screening trial for Atrium; Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Rambam Medical Center
- Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CS1 & heart monitor - AF patients
CS1 & heart monitor -Healthy volunteers
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Safety of CardicacSense1
Incidence and severity of device related Adverse Events
Secondary Outcome Measures
Usability
Ease of use of the CardiacSense1 device based on user questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03477734
Brief Title
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
Official Title
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
June 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardiacSense Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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). Study design as as follows:
100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).
All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference
For PPG analysis, each one hour will be considered as an event:
If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then it shall be considered a "Non-A-Fib hour".
For ECG analysis, each measurement of between 1-3 minutes will be considered an event.
If A-Fib is present at that specific measurement, then it shall be considered an "A-Fib event" If A-fib was not present at that specific measurement, then it shall be considered a "Non-A-Fib hour".
Sensitivity (true positive) is defined as the percentage of Holter defined "A-fib hours"/"A-Fib event" found by PPG/ECG.
The asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of Holter defined "Non-A-fib hours"/"A-Fib event" found by PPG/ECG. The required specificity is 90%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrium; Fibrillation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Males and females, 50 of them diagnosed with atrial fibrillation (AF), and 50 healthy participants, at least 30% of each gender in each group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS1 & heart monitor - AF patients
Arm Type
Experimental
Arm Description
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
Arm Title
CS1 & heart monitor -Healthy volunteers
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CS1 & heart monitor
Intervention Description
Daily activities while wearing the investigational device as well as the control device
Primary Outcome Measure Information:
Title
CardicacSense1 atrial fibrillation detection rate
Description
Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device.
Time Frame
24 to 48 hours
Title
Safety of CardicacSense1
Description
Incidence and severity of device related Adverse Events
Time Frame
24 to 48 hours
Secondary Outcome Measure Information:
Title
Usability
Description
Ease of use of the CardiacSense1 device based on user questionnaire
Time Frame
24 to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Havakuk, MD, PhD
Organizational Affiliation
Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
62431
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual data will be shared. Data analysis will include comparative overall data between investigational device and control device, as well as usability data
Learn more about this trial
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
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