NCT01463358

Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Bifascicular Block
• Syncope

Interventions

Type	Name	Description
DEVICE	DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)	pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block
DEVICE	DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)	pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.

Timeline

• Start date: 2005-03-01
• Primary completion: 2011-02-01
• Completion: 2011-05-01
• First posted: 2011-11-01
• Last updated: 2021-04-19
• Results posted: 2021-04-19

Locations

12 sites across 1 country: Italy