Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 101
- Locations
- 13
- Primary Endpoint
- 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
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.(2 years)
- Atrial Fibrillation(2 years)