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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01463358
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : January 6, 2016
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Bifascicular Block Syncope Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) Not Applicable

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


  • 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


  • 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Study Start Date : March 2005
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
Control group based only on backup pacing with lower rate 30 ppm
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)

Active Comparator: DDD60
Treatment arm based on full pacing support (60 Lower Rate)
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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Occurrence of first symptomatic episode (syncope or pre-syncope), independently from origin. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01463358

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Ospedale Santa Maria Annunziata
Bagno a Ripoli, Italy
Azienda Ospedaliera S. Sebastiano
Caserta, Italy
Ospedale Valduce
Como, Italy
Azienda Ospedaliera Osp. Maggiore
Crema, Italy
Nuovo Ospedale S. Giovanni di Dio
Firenze, Italy
Ospedale Villa Scassi
Genova, Italy
Ospedale Umberto I
Mestre, Italy
Ospedale GB Grassi
Ostia - Roma, Italy
Ospedale Civile G. De Lellis
Rieti, Italy
Azienda Ospedaliera S. Filippo Neri
Roma, Italy
Ospedale Sandro Pertini
Roma, Italy
Policlinico Casilino
Roma, Italy
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Massimo Santini, MD,FESC,FACC Ospedale San Filippo Neri, Roma, Italy
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boston Scientific Corporation Identifier: NCT01463358    
Other Study ID Numbers: GDT-20040601-PRESS-1
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: October 2011
Keywords provided by Boston Scientific Corporation:
Bifascicular block
Bradycardia pacing
Additional relevant MeSH terms:
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Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases