N/A Completed N=101 Randomized Treatment

Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Bifascicular Block · Syncope

Source: ClinicalTrials.gov NCT01463358 ↗

Enrolled (actual)

101

Serious AEs

55.5%

Results posted

Apr 2021

Primary outcomePrimary: 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 — 16; 7 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	16; 7	—
SECONDARY Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.	22; 13	—
SECONDARY Atrial Fibrillation	9; 18	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01463358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.