Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block — PRESS  

Syncope Clinical Trial

Official title: Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Bifascicular Block
• Syncope

• NCT number: NCT01463358
• Study type: Interventional
• Source: Boston Scientific Corporation
• Status: Completed
• Phase: N/A
• Start date: March 2005
• Completion date: May 2011