N/A
Completed N=175
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
Pacemaker Indication
Source: ClinicalTrials.gov NCT00916344 ↗
Enrolled (actual)
175
Serious AEs
29.7%
Results posted
Sep 2011
Primary outcomePrimary: Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) — -0.01 Volt
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) |
-0.01 | — |
| SECONDARY Complication Free Rate |
99 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00916344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.