Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
NCT ID: NCT01463358
Last Updated: 2021-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2005-03-31
2011-05-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DDI30
Control group based only on backup pacing with lower rate 30 ppm
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.
DDD60
Treatment arm based on full pacing support (60 Lower Rate)
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
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one episode of syncope during last 6 months from the enrollment
Exclusion Criteria
* Patients with vasovagal syndrome by positive TTT or carotid sinus syndrome
* Patients with Chronic Atrial Fibrillation
* Patients with Atrial Ventricular Block induces at EPS
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Massimo Santini, MD,FESC,FACC
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Filippo Neri, Roma, Italy
Locations
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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
Florence, , 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
Countries
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References
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Brignole M, Donateo P, Tomaino M, Massa R, Iori M, Beiras X, Moya A, Kus T, Deharo JC, Giuli S, Gentili A, Sutton R; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Benefit of pacemaker therapy in patients with presumed neurally mediated syncope and documented asystole is greater when tilt test is negative: an analysis from the third International Study on Syncope of Uncertain Etiology (ISSUE-3). Circ Arrhythm Electrophysiol. 2014 Feb;7(1):10-6. doi: 10.1161/CIRCEP.113.001103. Epub 2013 Dec 12.
Santini M, Castro A, Giada F, Ricci R, Inama G, Gaggioli G, Calo L, Orazi S, Viscusi M, Chiodi L, Bartoletti A, Foglia-Manzillo G, Ammirati F, Loricchio ML, Pedrinazzi C, Turreni F, Gasparini G, Accardi F, Raciti G, Raviele A. Prevention of syncope through permanent cardiac pacing in patients with bifascicular block and syncope of unexplained origin: the PRESS study. Circ Arrhythm Electrophysiol. 2013 Feb;6(1):101-7. doi: 10.1161/CIRCEP.112.975102. Epub 2013 Feb 6.
Other Identifiers
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GDT-20040601-PRESS-1
Identifier Type: -
Identifier Source: org_study_id
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