Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01463358
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2011-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESS
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: