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

Biotronik

Status: Completed

Conditions: Pacemaker Indication

Treatments: Device: EVIA Pacemaker

Study type: Interventional

Funder types: Industry

Identifiers

NCT00916344

38-1

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

175 participants in 1 patient group

Pacemaker therapy

Experimental group

Treatment:

Device: EVIA Pacemaker