ClinicalTrials.gg
Status unknownNCT03396133Updated Jul 28, 2020

Efficacy of Snap on Symptomatic Arrhythmia

An interventional study of Snap in Arrhythmia, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 46 studies in Arrhythmias, Cardiac with a site in China — 21 open to participants now, 24 under way, none of them phase 3. Arrhythmias, Cardiac · China.

Planned enrollment
15th of 27
120 · median 130
Started
2018
with 1 other
No phase
20 of 46
4 open now
Registered
10th of 46
by date
Lead sponsor
3 of 46
The First Affiliated Hospital with Nanjing Medical University

Among the 46 studies in Arrhythmias, Cardiac with a site in China, this one is the 15th largest by planned enrollment of the 27 interventional ones, is one of 2 that started in 2018, is one of 20 with no phase, and was the 10th registered.

By phase

46 studies; the count open now beside each. This study's row is marked.

No phasethis study20 · 4 open
Observational19 · 14 open
Phase 43 · 1 open
Phase 22 · 2 open
Phase 11 · 0 open
Phase 31 · 0 open

By the year they started

First in 1983; this study’s year is marked. 2 started in 2018.

Size and results

Median enrollment 130 across the 27 interventional studies, 1,000 across the 19 observational. Of the 16 that completed or were terminated, 6 (38%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 46 studies in Arrhythmias, Cardiac with a site in China, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Arrhythmia

Keywords

  • Snap
  • symptomatic arrhythmia
  • diagnosis
  • follow-up
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • symptomatic arrhythmia

Exclusion criteria

Exclusion Criteria:

  • can not use the Snap instrument and Sign
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Snap group

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

    Diagnostic Test: Snap

  • No intervention
    RC group

    patients in the RC arm accepted normal methods

Interventions

  • Diagnostic testSnap

    screen, transmission, and analysis ECG automated

06

What researchers measure

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.

    Time frame: 3-month

Secondary outcomes

  1. 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.

    Time frame: 3-month

07

Study locations

1 of 2 sites recruiting
  • Dyno
    Nanjing, Jiangsu 210029, China
    Recruiting
  • the First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210029, China
    Not yet recruiting
08

References and documents

Publications

  • 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. PubMed 28851729 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2018 (actual). Primary completion is estimated for Nov 2020, 25 months after the start.

Of 171 non-industry interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 25 months is below that.

Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2017
First posted
Jan 10, 2018
StartActual
Oct 30, 2018
Primary completionEst.
Nov 30, 2020
CompletionEst.
Dec 1, 2020
Last update
Jul 28, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03396133
Responsible party
Chunjian Li (principal investigator, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Jan 10, 2018
Start date
Oct 30, 2018
Primary completion
Nov 30, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Jul 28, 2020

Study contacts

Chun-Jian Li, PHD
Contact
lijay@njmu.edu.cn
13701465229 ext. 86
Jin-Shuang Li, MD
Contact
gd_l2000@163.com
13773998967 ext. 86
Chun-Jian Li, PHD
study chair · The First Affiliated Hospital with Nanjing Medical University
Jin-Shuang Li, MD
principal investigator · Suqian People's Hospital of Nanjing Drum Tower Hospital Group
Liang-Hong Ying, MD
study chair · The First Affiliated Hospital with Nanjing Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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