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

Boston Scientific

Status

Completed

Conditions

Syncope

Bifascicular Block

Treatments

Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01463358

GDT-20040601-PRESS-1

Details and patient eligibility

About

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.

Full 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

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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