Electrophysiological Mechanisms and Inhibitory Cardiac Syncope (ELICA)

University of Campania "Luigi Vanvitelli"

Status and phase: Completed; Phase 1

Conditions: Syncope Recurrent

Treatments: Device: pacemaker

Study type: Interventional

Funder types: Other

Identifiers

NCT02861274

7.2016

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

electrophysiological testing

Active Comparator group

Description:

Patients will receive a pacemaker.

Treatment:

Device: pacemaker

control group

No Intervention group

Description:

These subjects will receive cardicor® (beta blockers).