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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
  Purpose

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
Syncope
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 Guidant 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of first symptomatic episode (syncope or pre-syncope), independently from origin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
DDI30
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463358

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

No publications provided by Guidant Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT01463358     History of Changes
Other Study ID Numbers: GDT-20040601-PRESS-1
Study First Received: June 27, 2011
Last Updated: October 28, 2011
Health Authority: Italy: National Bioethics Committee

Keywords provided by Guidant Corporation:
Syncope
Bifascicular block
Bradycardia pacing

Additional relevant MeSH terms:
Syncope
Consciousness Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Unconsciousness

ClinicalTrials.gov processed this record on November 25, 2014