Status:

COMPLETED

Efficacy of Transcatheter Ablation Using Anatomic Approach of Ganglionated Plexi Located in the Right Atrium to Prevent Neuromediated Cardioinhibitory Syncope

Lead Sponsor:

Policlinico Casilino ASL RMB

Conditions:

Neuromediated Cardioinhibitory Syncope

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

Cardioinhibitory neurocardiogenic syncope (CNS) or vasovagal syncope, is the most frequent aetiology of syncope in young people without apparent cardiac or neurological pathology. It is usually caused...

Eligibility Criteria

Inclusion

  • Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be enrolled in the study.
  • Inclusion criteria:
  • age between 18 and 60 years
  • 3 syncopal episodes at least of likely CNS in the previous 2 years
  • marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop recorder registration \[7\].
  • Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.
  • Exclusion criteria:
  • documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection fraction lower than 50%)
  • documented tachyarrhythmias as possible causes of symptoms
  • channelopathies (Brugada syndrome, LQT or SQT syndrome)
  • ventricular preexcitation
  • symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement
  • pregnancy in women
  • previous cardiac pacemaker implantation.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2020

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT01814228

    Start Date

    September 1 2013

    End Date

    April 1 2020

    Last Update

    April 27 2020

    Active Locations (1)

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    Policlinico Casilino

    Rome, Lazio, Italy, 00169