Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block (PRESS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT01463358
First received: June 27, 2011
Last updated: October 28, 2011
Last verified: October 2011

June 27, 2011
October 28, 2011
March 2005
February 2011   (final data collection date for primary outcome measure)
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01463358 on ClinicalTrials.gov Archive Site
Occurrence of first symptomatic episode (syncope or pre-syncope), independently from origin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

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.

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bifascicular Block
  • Syncope
  • 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
    Other Name: INSIGNIA® pacing systems Guidant (Boston Scientific)
  • 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.
    Other Name: INSIGNIA® pacing systems Guidant (Boston Scientific)
  • DDI30
    Control group based only on backup pacing with lower rate 30 ppm
    Intervention: Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
  • Active Comparator: DDD60
    Treatment arm based on full pacing support (60 Lower Rate)
    Intervention: Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
May 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01463358
GDT-20040601-PRESS-1
Yes
Guidant Corporation
Guidant Corporation
Not Provided
Principal Investigator: Massimo Santini, MD,FESC,FACC Ospedale San Filippo Neri, Roma, Italy
Guidant Corporation
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP