Trial Outcomes & Findings for Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias (NCT NCT03769207)

NCT ID: NCT03769207

Last Updated: 2020-10-20

Results Overview

Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: During ambulatory ECG Monitoring (up to 8 days)
• Results posted on: 2020-10-20

Participant Flow

Participants who received an irregular pulse notification or who had an AF classification on the ECG app and then called the sponsor's customer support were invited to download the study app and enroll. They had a remote study visit, were sent an ECG patch to wear and return for analysis, and had a second remote visit to review the findings.

Participant milestones

Measure	Ambulatory ECG Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
Overall Study STARTED	17
Overall Study Attended First Study Visit	11
Overall Study ECG Patch Shipped	11
Overall Study ECG Patch Returned and Readable	9
Overall Study Attended Second Study Visit	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias

Baseline characteristics by cohort

Measure	Ambulatory ECG n=17 Participants Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
Age, Continuous	52.4 years STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eeastern or North African	1 Participants n=5 Participants
Race/Ethnicity, Customized Preferred not to respond	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: During ambulatory ECG Monitoring (up to 8 days)

Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

Outcome measures

Measure	Ambulatory ECG n=9 Participants Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration	0.11 Proportion of participants Interval 0.003 to 0.48

SECONDARY outcome

Timeframe: During ambulatory ECG Monitoring (up to 8 days)

Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

Outcome measures

Measure	Ambulatory ECG n=9 Participants Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
Arrhythmias Other Than AF	0 Proportion of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Between 15 to 90 days following enrollment

Outcome measures

Measure	Ambulatory ECG n=9 Participants Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
Self-reported Contact With Healthcare Provider	0.56 Proportion of participants Interval 0.21 to 0.86

Adverse Events

Ambulatory ECG

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ambulatory ECG n=17 participants at risk Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor
Psychiatric disorders Anxiety	11.8% 2/17 • Number of events 2 • 9 months (participants may have reported adverse events at any time from enrollment to close of study)
Cardiac disorders Elevated Heart Rate	5.9% 1/17 • Number of events 2 • 9 months (participants may have reported adverse events at any time from enrollment to close of study)
General disorders Fatigue	5.9% 1/17 • Number of events 1 • 9 months (participants may have reported adverse events at any time from enrollment to close of study)
Skin and subcutaneous tissue disorders Rash	17.6% 3/17 • Number of events 3 • 9 months (participants may have reported adverse events at any time from enrollment to close of study)

Additional Information

Marco Perez, Associate Professor of Medicine

Stanford University

Phone: (650) 723-9363

Email: mvperez@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place