Efficacy of Snap on Symptomatic Arrhythmia

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03396133
• Other study ID #: 009
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Chun-Jian Li, PHD
• Phone: 13701465229
• Email: lijay[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• symptomatic arrhythmia

Exclusion Criteria:

• can not use the Snap instrument and Sign informed consent

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Diagnostic Test:
• Snap
screen, transmission, and analysis ECG automated

Locations

Country	Name	City	State
China	Dyno	Nanjing	Jiangsu
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia	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.	3-month
Secondary	Evaluating the patients' quality of life	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.	3-month