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Search / Trial NCT01509534

Guideline-based Pacing Therapy for Reflex Syncope

Launched by GRUPPO ITALIANO MULTIDISCIPLINARE PER LO STUDIO DELLA SINCOPE · Jan 12, 2012

Trial Information

Current as of June 19, 2025

Completed

Keywords

Pacemaker Implantable Loop Recorder Syncope

ClinConnect Summary

Background Divergence of opinion exists regarding the efficacy of cardiac pacing in patients affected by different forms of reflex syncope.

Definitions.

Severe syncope is defined when:

* it is perceived by patient that it alters his/her quality of life, and
* is unpredictable because occurs without, or with very short prodromes \< 10 sec (thus exposing patients to risk of trauma) or, if preceded by prodromes, syncope recurs despite appropriate therapies (CPM or drugs).

Recurrent syncopes: at least 2 episodes during the last year (including the index episode) or 3 episodes during the las...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients affected by severe, recurrent, certain or suspected (undetermined) reflex syncopes, aged ≥ 40 years.
  • Exclusion Criteria:
  • Reflex syncopes due to reversible causes, e.g., vasoactive drugs, concomitant diseases, etc
  • Suspected of certain cardiac syncope
  • Syncope caused by orthostatic hypotension
  • Non-syncopal causes of transient loss of consciousness

About Gruppo Italiano Multidisciplinare Per Lo Studio Della Sincope

The Gruppo Italiano Multidisciplinare per lo Studio della Sincope (GIMSS) is a leading clinical research organization dedicated to advancing the understanding and management of syncope through multidisciplinary collaboration. Comprising a network of experts from various medical specialties, GIMSS focuses on conducting innovative clinical trials, fostering research initiatives, and disseminating findings to improve patient outcomes. With a commitment to rigorous scientific methodology and ethical standards, GIMSS aims to enhance the clinical landscape of syncope by developing evidence-based guidelines and promoting best practices in diagnosis and treatment.

Locations

Reggio Emilia, , Italy

Firenze, , Italy

Bolzano, , Italy

Catania, , Italy

Empoli, , Italy

Firenze, , Italy

Lavagna, , Italy

Taranto, , Italy

Patients applied

0 patients applied

Trial Officials

Michele Brignole, MD

Principal Investigator

Ospedali del Tigullio, Lavagna, Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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