Efficacy of Snap on Symptomatic Arrhythmia

Not Applicable

• Conditions: Arrhythmia
• Interventions: Diagnostic Test: Snap

• Registration Number: NCT03396133
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-10
• Study Start: 2018-10-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• symptomatic arrhythmia

Exclusion Criteria

• can not use the Snap instrument and Sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Snap group	Snap	individuals in this arm used Snap according to the instruction on time and screened at the symptomatic

Primary Outcome Measures

Name	Time	Method
Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia	3-month	Participants 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 Outcome Measures

Name	Time	Method
Evaluating the patients' quality of life	3-month	Using 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.

Trial Locations

Locations (2)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Dyno; 🇨🇳 Nanjing, Jiangsu, China