Clinical trial NCT03477734: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atrium; Fibrillation
Lead sponsor: CardiacSense Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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%.

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

Primary outcomes:
measure: CardicacSense1 atrial fibrillation detection rate
timeFrame: 24 to 48 hours
measure: Safety of CardicacSense1
timeFrame: 24 to 48 hours
Secondary outcomes:
measure: Usability
timeFrame: 24 to 48 hours
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel
name: Ofer Havakuk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: