Bifascicular Block, Syncope
Conditions
Keywords
Syncope, Bifascicular block, Bradycardia pacing
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
Interventions
DEVICEDDD60 (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
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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 | 52 |
| Total | 101 |
Baseline characteristics
| Characteristic | DDI30 | DDD60 | Total |
|---|---|---|---|
| Age, Continuous | 78 years STANDARD_DEVIATION 8 | 77 years STANDARD_DEVIATION 8 | 77 years STANDARD_DEVIATION 8 |
| Region of Enrollment Italy | 49 participants | 52 participants | 101 participants |
| Sex: Female, Male Female | 23 Participants | 17 Participants | 40 Participants |
| Sex: Female, Male Male | 26 Participants | 35 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 49 | 2 / 52 |
| other Total, other adverse events | 22 / 49 | 20 / 52 |
| serious Total, serious adverse events | 33 / 49 | 23 / 52 |
Outcome results
Primary
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
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
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DDI30 | 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 | 16 Participants |
| DDD60 | 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 | 7 Participants |
Secondary
Atrial Fibrillation
patients presenting with at least one episode of atrial fibrillation during the 2 years follow up period
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DDI30 | Atrial Fibrillation | 9 Participants |
| DDD60 | Atrial Fibrillation | 18 Participants |
Secondary
Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DDI30 | Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin. | 22 Participants |
| DDD60 | Occurrence of First Symptomatic Episode (Syncope or Pre-syncope), Independently From Origin. | 13 Participants |