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

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: June 27, 2011
Last updated: January 5, 2016
Last verified: October 2011

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 Intervention
Bifascicular Block
Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

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

Enrollment: 101
Study Start Date: March 2005
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01463358

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
Principal Investigator: Massimo Santini, MD,FESC,FACC Ospedale San Filippo Neri, Roma, Italy
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation Identifier: NCT01463358     History of Changes
Other Study ID Numbers: GDT-20040601-PRESS-1
Study First Received: June 27, 2011
Last Updated: January 5, 2016

Keywords provided by Boston Scientific Corporation:
Bifascicular block
Bradycardia pacing

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 22, 2017