N/A
N=101
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Bifascicular Block · Syncope
Bottom Line
View on ClinicalTrials.gov: NCT01463358 ↗Enrolled (actual)
101
Serious AEs
55.5%
Results posted
Apr 2021
Primary outcome: 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 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Feb 2011
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 | — |
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.
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
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.