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Completed

NCT Number: NCT01053832

Ventricular Pace Suppression Study

Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

Completed

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Key information

Conditions

Pacemaker Indication

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Coburg gGmbH, Coburg, Bavaria, Germany

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About this study

The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Paroxysmal AV block and/or Sinus Node Dysfunction
  • DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability

Exclusion criteria

  • Permanent AV block III°
  • Permanent Atrial Fibrillation/ Flutter
  • Require mode other than DDD(R)-ADI(R) or DDD(R)
  • Have a life expectancy of less than six months
  • Expected to receive heart surgery within six months
  • Enrolled in another cardiac investigation

Treatment and study plan

VpS algorithm in EVIA and ENTOVIS pacemakers

Device

For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched.

Primary outcomes

  1. Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers.

    Time frame: 6-8 months

Secondary outcomes

  1. A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker.

    Time frame: 6-8 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Ventricular Pace Suppression Study With the EVIA/ENTOVIS DR-T/DR Pacemaker

Acronym: VpS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2010
Registry last updated
Oct 25, 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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