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Completed

NCT Number: NCT03049722

Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.

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Key information

Conditions

Cardiac Pacemaker, Artificial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouge Valley Centenary, Scarborough Village, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker
  • Possessing 1st or 3rd degree AV block
  • Implanted with Biotronik bipolar RA and RV leads
  • Implantation date should be at least 4 months prior to this study

Exclusion criteria

  • Patient is a minor (18 years old or younger)
  • Patient is pregnant or breast-feeding
  • Patient does not have the legal capacity to provide consent
  • Patient has Mobitz type I or Mobitz type II heart block
  • Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats.
  • Patient is participating in other clinical studies during the clinical study
  • Patient is strictly pacemaker dependent (physician discretion)

Treatment and study plan

pacemaker

Device

Primary outcomes

  1. Correlation analysis between measured PWD and optimal AVD.

    Time frame: Up to 6 hours

    Data analysis will be performed on the collected data to relate P wave duration (PWD) measured from the far field IEGM to the optimal AVD determined from the hemodynamic assessment.

Sponsors and collaborators

Lead sponsor

Biotronik Canada Inc

Industry

Registry information

Official study title

Clinical Investigation Plan for the AVOPT Data Collection

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 10, 2017
Registry last updated
Feb 10, 2017

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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