Diagnosis of Arrhythmias in Syncope by Pocket-ECG III® or Conventional Holter

NCT02614235 | Completed

• 1 other identifier: EP-CHUAC-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether continuous cardiac telemetry with the Pocket-ECG III® system is more useful than conventional Holter to find out the cause of syncope

Conditions

Syncope

Keywords

Cardiac Arrhythmia; Syncope; Ambulatory Electrocardiography Monitoring

Outcome Measures

Primary Outcomes (3)

• number of etiology diagnosis of syncope

  two months

• length of time until diagnosis

  two months

• Overall and per diagnosis costs

  Two months

Secondary Outcomes (1)

• length of properly analyzable registry

  two months

Study Arms (2)

Pocket-ECG III System

EXPERIMENTAL

After signing written informed consent, a Pocket-ECG III® system will be given to the patient. All participants will be monitored by the Pocket-ECG® system until a diagnosis is achieved or for a maximum of two months (whatever it happens first). Everyday daily reports sent via e-mail by the manufacturer company (MEDICALgorithmics© S.A.) will be reviewed by the investigator team; in case of a diagnosis event (according to prespecified diagnostic criteria from the European Society of Cardiology), appropriate treatment will be applied.

Device: Pocket-ECG III system

Conventional Holter

ACTIVE COMPARATOR

Every patient will be his/her own control. Conventional 24-hours Holter monitoring will be simulated using data obtained by the Pocket-ECG III® system in the first 24 hours, ignoring the registries of the rest of days. Two and Three 24-hours conventional Holter strategies will also be simulated analyzing data from first 24 hours and 1-2 additional days, respectively, chosen by means of a random number creation system which will identify the days of registry to be considered.

Device: Pocket-ECG III system

Interventions

Pocket-ECG III system DEVICE

Continuous cardiac telemetry until diagnosis or a maximum of two months

Conventional Holter; Pocket-ECG III System

Eligibility Criteria

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

You may qualify if:

• Patients with syncope refered to perform 24-hours conventional Holter who fulfill at least one of the following conditions:
• ≥2 episodes of syncope in the last year, provided that they are not typical vasovagal syncope, and/or
• ≥1 episode of syncope with any criterion of suspicion of cardiac-arrhythmic aetiology, according to current European Guidelines about management of syncope

You may not qualify if:

• Carrier of any cardiac implantable electronic device or internal loop recorder, as well as stablished indication for it according to current guidelines.
• Aetiologic diagnosis of syncope already known.
• Left ventricular ejection fraction ≤35%.
• Unability to perform the monitorization

Sponsors & Collaborators

• Complexo Hospitalario Universitario de A Coruña: lead

Study Sites (1)

Complexo Hospitalario Universitario de A Coruna

A Coruña, 15006, Spain

Location

MeSH Terms

Conditions

Syncope; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Study Officials

• Ignacio Mosquera, MD

  Complexo Hospitalario Universitario A Coruna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: February 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

ES (1)