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OpenTrials
Completed

NCT Number: NCT00627328

The Atrial High Rate Episodes in Pacemaker Patients

Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.

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Key information

Conditions

Arrhythmia Arrhythmia, Sinus Arrhythmias, Cardiac Atrial Fibrillation Atrioventricular Block Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ashford, Australia

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About this study

The purpose of this study is to assess the incidence of fast heart rates that originate in the upper chamber of the heart (atrial tachyarrhythmias) in pacemaker patients that have not been previously diagnosed with this condition. The study will also look at how the diagnostic feature in the pacemaker that detects atrial tachyarrhythmias helps physicians with the medical management of patients' heart rhythm.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications
  • No previous history of pacemaker implantation
  • Patients 50 years of age or older

Exclusion criteria

  • Patients with a history of atrial tachyarrhythmias (primary arm of study)
  • Patients with medical conditions that would limit study participation
  • Patients inaccessible for follow-up at the study center
  • Patients incapable of providing Informed Consent
  • Patients with NYHA classification of IV
  • Patients with a history of neurocardiogenic syncope, long QT syndrome, or Hypertrophic Obstructive Cardiomyopathy (HOCM)
  • Patients taking Sotalol or Amiodorone
  • Patients with a history of a prior ICD or pacemaker implantation.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients

Important dates

Study start
2000
Study completion
2004
First posted
Mar 3, 2008
Registry last updated
Mar 3, 2008

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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