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OpenTrials
Completed

NCT Number: NCT02861274

Electrophysiological Mechanisms and Inhibitory Cardiac Syncope

OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio inhibitory response to the head up tilt testing (HUT) evaluation.

METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without asystolia (2A type) have been enrolled in this study. These patients have been studied by electrophysiological study (ES). After ES patients have been differently treated (interventional treatment group A, v/s drug therapy group), and followed up during 360 days, to evaluate syncope recurrences.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age more than 18, normal heart function, more than 1 syncope event for year.

Exclusion criteria

  • age inferior 18 years, history of myocardial infarction, heart failure, structural heart disease.

Treatment and study plan

pacemaker

Device

Primary outcomes

  1. syncope recurrence

    Time frame: 360 days

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

ELectrophysiological Mechanisms Underlying the Inhibitory CArdiac Syncope: Therapeutic and Prognostic Implications The ELICA Study

Acronym: ELICA

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 10, 2016
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.