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Efficacy of Snap on Symptomatic Arrhythmia

Assessment of Portable Remote Health Monitor Using the Snap to Symptomatic Arrhythmia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03396133
Enrollment
120
Registered
2018-01-10
Start date
2018-10-30
Completion date
2020-12-01
Last updated
2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

Keywords

Snap, symptomatic arrhythmia, diagnosis, follow-up

Brief summary

Participants in the Snap arm were instructed to undertake once-day recording and transmission of a 30-second single-lead iECG trace to a secure server, plus additional submissions if symptomatic over a 3-month period. Snap traces were analyzed by an automated analysis software and cardiologists. Clinical review and appropriate care was arranged for those clinically significant arrhythmia. Patients in the RC group were followed up as normal methods including ECG, Holter.

Detailed description

Individuals with symptomatic arrhythmia without known arrhythmia were recruited. Participants were required to have access to the internet via WiFi and to be able to operate the Snap system after simple instruction. Written consent was obtained, and eligible participants were randomized (1:1) to an intervention (Snap) group or RC group.

Interventions

DIAGNOSTIC_TESTSnap

screen, transmission, and analysis ECG automated

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* symptomatic arrhythmia

Exclusion criteria

* can not use the Snap instrument and Sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia3-monthParticipants in Snap group acquired ECG once od according to the rules and transmitted ECG immediately once symptom appeared between 3-month. Patients in the routine treatment (RT) group were administrated normal diagnostic techniques. At 3-month, compared the incidence atrial arrhythmia(atrial premature beats and atrial tachycardia) and ventricula arrhythmia(ventricular premature beats and ventricular tachycardia) between two groups.

Secondary

MeasureTime frameDescription
Evaluating the patients' quality of life3-monthUsing RAND 36-Item Short Form Health Survey (SF-36) 1.0 Questionnaire items assessed the quality of life of participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The total scale ranges from 35 to 145. The higher the total score, the better the patient's quality of life.

Countries

China

Contacts

Primary ContactChun-Jian Li, PHD
lijay@njmu.edu.cn13701465229
Backup ContactJin-Shuang Li, MD
gd_l2000@163.com13773998967

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026