CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 101 enrolled
Drug / intervention
DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01463358
NCT01463358N/ACompleted
CompareCT.gov

Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Boston Scientific Corporation·interventional·Posted Nov 1, 2011·Updated Apr 19, 2021

In Brief

A clinical study evaluating DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) for Bifascicular Block and Syncope. Completed, enrolled 101 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBifascicular Block, Syncope
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 1, 2011
Enrollment StartMar 1, 2005
Primary CompletionFeb 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 14.7 years ago

Interventions

DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)device

pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block

DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)device

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.