Efficacy of Snap on Symptomatic Arrhythmia

NCT03396133 | Unknown

• 1 other identifier: 009
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Arrhythmia

Keywords

Snap; symptomatic arrhythmia; diagnosis; follow-up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluating the patients' quality of life

  3-month

Study Arms (2)

Snap group

EXPERIMENTAL

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

Diagnostic Test: Snap

RC group

NO INTERVENTION

patients in the RC arm accepted normal methods

Interventions

Snap DIAGNOSTIC_TEST

screen, transmission, and analysis ECG automated

Snap group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic arrhythmia

You may not qualify if:

• can not use the Snap instrument and Sign informed consent

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (2)

Dyno

Nanjing, Jiangsu, 210029, China

RECRUITING

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Related 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. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.

  PMID: 28851729 RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chun-Jian Li, PHD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• Jin-Shuang Li, MD

  Suqian People's Hospital of Nanjing Drum Tower Hospital Group

  PRINCIPAL INVESTIGATOR

• Liang-Hong Ying, MD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Chun-Jian Li, PHD

CONTACT

13701465229; lijay@njmu.edu.cn

Jin-Shuang Li, MD

CONTACT

13773998967; gd_l2000@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 10, 2018
• Study Start: October 30, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 1, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

CN (2)