N/A N=175 Treatment

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

Pacemaker Indication

Bottom Line

View on ClinicalTrials.gov: NCT00916344 ↗

Enrolled (actual)

175

Serious AEs

29.7%

Results posted

Sep 2011

Primary outcome: Primary: Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement) — -0.01 Volt

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EVIA Pacemaker (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Biotronik SE & Co. KG
Primary completion: Feb 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.