Efficacy of Snap on Symptomatic Arrhythmia

NCT ID: NCT03396133

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Snap group

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

Group Type EXPERIMENTAL

Snap

Intervention Type DIAGNOSTIC_TEST

screen, transmission, and analysis ECG automated

RC group

patients in the RC arm accepted normal methods

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Snap

screen, transmission, and analysis ECG automated

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* symptomatic arrhythmia

Exclusion Criteria

* can not use the Snap instrument and Sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chunjian Li

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun-Jian Li, PHD

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Jin-Shuang Li, MD

Role: PRINCIPAL_INVESTIGATOR

Suqian People's Hospital of Nanjing Drum Tower Hospital Group

Liang-Hong Ying, MD

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Dyno

Nanjing, Jiangsu, China

Site Status RECRUITING

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Chun-Jian Li, PHD

Role: CONTACT

13701465229 ext. 86

Jin-Shuang Li, MD

Role: CONTACT

13773998967 ext. 86

Facility Contacts

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Jin-Shuang Li, MD

Role: primary

18751070788 ext. 86

Jin-Shuang Li, MD

Role: primary

18751070788

References

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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.

Reference Type RESULT
PMID: 28851729 (View on PubMed)

Other Identifiers

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009

Identifier Type: -

Identifier Source: org_study_id

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