AdvisaTM IPG Clinical Evaluation Study

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.

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.