Electrophysiological Mechanisms and Inhibitory Cardiac Syncope (ELICA)
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|ClinicalTrials.gov Identifier: NCT02861274|
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Syncope Recurrent||Device: pacemaker||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ELectrophysiological Mechanisms Underlying the Inhibitory CArdiac Syncope: Therapeutic and Prognostic Implications The ELICA Study|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||September 2015|
Active Comparator: electrophysiological testing
Patients will receive a pacemaker.
No Intervention: control group
These subjects will receive cardicor® (beta blockers).
- syncope recurrence [ Time Frame: 360 days ]