Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Last updated: March 23, 2021
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

N/A

Condition

Dizzy/fainting Spells

Cataplexy

Low Blood Pressure (Hypotension)

Treatment

N/A

Clinical Study ID

NCT01463358
GDT-20040601-PRESS-1
  • Ages > 18
  • All Genders

Study Summary

Study Objective

The purpose of this study is to evaluate the efficacy of bradycardia pacing with respect to patient symptoms in patients with bifascicular block and syncope of unexplained origin.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Evidence of Bifascicular block
  • At least one episode of syncope during last 6 months from the enrollment

Exclusion

Exclusion Criteria:

  • Patients with Brady-tachy syndrome that needs of pacemaker to prevent the symptomaticbradycardia o symptomatic tachycardia arrhythmia
  • Patients with vasovagal syndrome by positive TTT or carotid sinus syndrome
  • Patients with Chronic Atrial Fibrillation
  • Patients with Atrial Ventricular Block induces at EPS

Study Design

Total Participants: 101
Study Start date:
March 01, 2005
Estimated Completion Date:
May 31, 2011

Study Description

Primary endpoint

First occurrence of a composite of Syncope of any origin OR Presyncopal episode with documented cardioinhibitory origin OR Atrioventricular block of any degree; all associated with patient symptoms

Design:

  • Randomized, prospective, single blinded, two parallel arms

  • Treatment group : DDD60 - programmed in DDD mode / 60 lower limit

  • Control Group: DDI30 - programmed in DDI mode / 30 lower limit

  • Randomization type: block randomization: Block size: 4, allocation ratio 1:1

Sample: 100 patients

Population

  • Patients with bifascicular block with at least one syncopal episode within the last 6 months preceding enrollment.

  • Patients should be negative to a series of pre-enrollment screening in order to exclude:

  • Brady-tachy syndrome, vasovagal syncope or carotid sinus syndrome, atrial fibrillation, inducible AV block

  • Ejection fraction >=40%

  • Mean nocturnal heart rate >=35 bpm

Connect with a study center

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli,
    Italy

    Site Not Available

  • Azienda Ospedaliera S. Sebastiano

    Caserta,
    Italy

    Site Not Available

  • Ospedale Valduce

    Como,
    Italy

    Site Not Available

  • Azienda Ospedaliera Osp. Maggiore

    Crema,
    Italy

    Site Not Available

  • Nuovo Ospedale S. Giovanni di Dio

    Firenze,
    Italy

    Site Not Available

  • Ospedale Villa Scassi

    Genova,
    Italy

    Site Not Available

  • Ospedale Umberto I

    Mestre,
    Italy

    Site Not Available

  • Ospedale GB Grassi

    Ostia - Roma,
    Italy

    Site Not Available

  • Ospedale Civile G. De Lellis

    Rieti,
    Italy

    Site Not Available

  • Azienda Ospedaliera S. Filippo Neri

    Roma,
    Italy

    Site Not Available

  • Ospedale Sandro Pertini

    Roma,
    Italy

    Site Not Available

  • Policlinico Casilino

    Roma,
    Italy

    Site Not Available

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