Atrial Tachyarrhythmia, Bradycardia
Conditions
Brief summary
The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).
Detailed description
The Advisa IPG is an investigational dual chamber pacemaker that provides rate-responsive bradycardia pacing and diagnostics and atrial tachycardia detection and therapy. The study will be a prospective, non-randomized, multicenter clinical study, conducted. To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Advisa device. Data will be collected at baseline (enrollment), implant, 1-, 3- and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.
Interventions
DEVICEAdvisa IPG
Implantable Pulse Generator will be implanted
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have an IPG indication for implantation of a dual chamber pacemaker. * Patients who are geographically stable and available for follow-up at the study center for the duration of the study. * Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.
Exclusion criteria
* Patients with a life expectancy less than the duration of the study. * Patients with a Class III indication for permanent pacing according to ACC/AHA/NASPE 2002 guidelines. * Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| USADE at 1 month post implant | 1 month | Confirm safety of the device by assessing the percentage of subjects with an unanticipated serious adverse device effect (USADE) at 1-month post-implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advisa IPG system performance | 1 month | System performance as observed during Holter recordings, Save-to-Disk data and Technical Observations. |
Countries
Czechia
Outcome results
None listed