Clinical trial NCT01463358: Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Official title: Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bifascicular Block
Syncope
Keywords: Syncope
Bifascicular block
Bradycardia pacing
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-11-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
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
timeFrame: 2 years
Secondary outcomes:
measure: Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.
timeFrame: 2 years
measure: Atrial Fibrillation
timeFrame: 2 years
Other outcomes:
Locations:
city: Bagno a Ripoli
country: Italy
facility: Ospedale Santa Maria Annunziata
city: Caserta
country: Italy
facility: Azienda Ospedaliera S. Sebastiano
city: Como
country: Italy
facility: Ospedale Valduce
city: Crema
country: Italy
facility: Azienda Ospedaliera Osp. Maggiore
city: Firenze
country: Italy
facility: Nuovo Ospedale S. Giovanni di Dio
city: Genova
country: Italy
facility: Ospedale Villa Scassi
city: Mestre
country: Italy
facility: Ospedale Umberto I
city: Ostia - Roma
country: Italy
facility: Ospedale GB Grassi
city: Rieti
country: Italy
facility: Ospedale Civile G. De Lellis
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Filippo Neri
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Policlinico Casilino
Study officials:
affiliation: Ospedale San Filippo Neri, Roma, Italy
name: Massimo Santini, MD,FESC,FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.