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NCT Number: NCT01463358

Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

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.

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Key information

Conditions

Bifascicular Block Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Santa Maria Annunziata, Bagno a Ripoli, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with Brady-tachy syndrome that needs of pacemaker to prevent the symptomatic bradycardia 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

Treatment and study plan

DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)

Device

pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block

Other names: INSIGNIA® pacing systems Guidant (Boston Scientific)

Primary outcomes

  1. Combined Endpoint Defined as First Occurrence Among the Following Events 1)Syncope Episode of Any Origin; 2)Presyncopal Episode With Documented Cardioinhibitory Origin 3) Atrioventricular Block of Any Degree Associated With Patient Symptoms

    Time frame: 2 years

    Number of participants experiencing syncope episodes, symptomatic pre-syncopal episodes associated with a device intervention (ventricular pacing) and symptomatic episodes associated with documentation of intermittent or permanent atrio-ventricular block

Secondary outcomes

  1. Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.

    Time frame: 2 years

  2. Atrial Fibrillation

    Time frame: 2 years

    patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: PRESS

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Nov 1, 2011
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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