Status:
COMPLETED
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Bifascicular Block
Syncope
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- Evidence of Bifascicular block
- At least one episode of syncope during last 6 months from the enrollment
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01463358
Start Date
March 1 2005
End Date
May 1 2011
Last Update
April 19 2021
Active Locations (12)
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1
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
2
Azienda Ospedaliera S. Sebastiano
Caserta, Italy
3
Ospedale Valduce
Como, Italy
4
Azienda Ospedaliera Osp. Maggiore
Crema, Italy