Bradycardia, Sudden Cardiac Death
Conditions
Brief summary
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
Detailed description
The Guidant ASSURE device is a fully featured pacemaker with additional atrial and ventricular tachyarrhythmia therapy features. The REASSURE AV study is a clinical evaluation to support approval of these features. This clinical study is intended to provide adequate performance data on two atrial tachyarrhythmia management features, namely the ATS and atrial ATP. In addition data will be collected to verify that the ventricular tachyarrhythmia rescue shock feature performs as intended in the clinical setting in combination with other pacemaker functions.
Interventions
DEVICEAV Therapy Assessment-B301 investigational device
Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient is willing and capable of providing informed consent at an approved clinical investigational center, and able to attend the investigational center as required by the protocol * Patient is implanted with an investigational B301 device as part of the REASSURE AV study
Exclusion criteria
\* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inappropriate Shock Free Rate | Three months post-implant | Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion Success Rate up to Three Months Post-implant | Three months post-implant | For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AV Therapy Assessment Group AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS)
AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
Ventricular tachyarrhythmia rescue shock feature
AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device | 211 |
| Total | 211 |
Baseline characteristics
| Characteristic | AV Therapy Assessment Group |
|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 211 Participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 211 |
| other Total, other adverse events | 17 / 211 |
| serious Total, serious adverse events | 52 / 211 |
Outcome results
Primary
Inappropriate Shock Free Rate
Incidences of ventricular shock therapy up to three months post implant. Rescue shocks are intended for the treatment of cardiac arrhythmias detected in the ventricle at rates greater than 220 bpm, including arrhythmias that originate in the atria if they are conducted at rates greater than 220 bpm as this can be life threatening if persistent. Shocks delivered for other reasons will be considered inappropriate shocks.
Time frame: Three months post-implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AV Therapy Assessment Group | Inappropriate Shock Free Rate | 97.2 % of shock free rates |
Secondary
Conversion Success Rate up to Three Months Post-implant
For a pacemaker patient who experiences a spontaneous high rate ventricular arrhythmia, the ASSURE device may provide rescue shocks, a faster and more effective response than external methods of rescue. Successful conversion of an episode is defined by conversion to either; sinus rhythm, sinus tachycardia or atrial pacing by one minute post therapy delivery.
Time frame: Three months post-implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AV Therapy Assessment Group | Conversion Success Rate up to Three Months Post-implant | 90.9 % of conversion rates |