Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker

Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker

The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.

Inclusion Criteria:

• Meet the indications for pacemaker therapy
• Understand the nature of the procedure
• Give informed consent
• Able to complete all testing required by the clinical protocol
• Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

• Meet none of the pacemaker indications
• Meet one or more of the contraindications
• Patients with chronic atrial fibrillation (dual chamber pacemaker only)
• Have a life expectancy of less than six months
• Cardiac surgery in the next six months
• Enrolled in another cardiac clinical investigation
• Have other medical devices that may interact with the implanted pacemaker