Prevention of Syncope by Cardiac Pacing in Patients With Bifascicular Block
- Conditions
- Bifascicular BlockSyncope
- Interventions
- Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
- Registration Number
- NCT01463358
- Lead Sponsor
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Evidence of Bifascicular block
- At least one episode of syncope during last 6 months from the enrollment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DDI30 DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) Control group based only on backup pacing with lower rate 30 ppm DDD60 DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific) Treatment arm based on full pacing support (60 Lower Rate)
- Primary Outcome Measures
Name Time Method 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 2 years Number of participants experiencing syncope episodes, symptomatic pre-syncopal episodes associated with a device intervention (ventricular pacing) and symptomatic episodes associated with documentation of intermittent or permanent atrio-ventricular block
- Secondary Outcome Measures
Name Time Method Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin. 2 years Atrial Fibrillation 2 years patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period
Trial Locations
- Locations (12)
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 Umberto I
🇮🇹Mestre, Italy
Ospedale Villa Scassi
🇮🇹Genova, 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