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Completed

NCT Number: NCT00916344

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

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Key information

Conditions

Pacemaker Indication

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux Haut-Lévêque

Pessac, Bordeaux, F - 33604, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVIA Pacemaker

Device

patient has standard indication for pacemaker therapy

Primary outcomes

  1. Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)

    Time frame: 1 month follow-up completed

    atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.

    atrial threshold test: measurable automatically or manually.

Secondary outcomes

  1. Complication Free Rate

    Time frame: 1- and 3- month follow-up completed

    Complication free rate (in %):

    1 minus(the number of possibly pacemaker related complications divided by the number of patients)

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2009
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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