The Atrial High Rate Episodes in Pacemaker Patients

Overview

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

Full Title of Study: “The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Detailed Description

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.

Arms, Groups and Cohorts

  • 1
    • pacemaker patients with previously diagnosed AT.
  • 2
    • pacemaker patients without previously diagnosed AT.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic Cardiac Rhythm and Heart Failure
  • Provider of Information About this Clinical Study
    • Diane Sahr, CRDM Clincial Research
  • Overall Official(s)
    • M. V. Orlov, MD, Principal Investigator, Tufts University School of Medicine
    • J.K. Ghali, MD, Principal Investigator, Louisiana State University Health Sciences Center in New Orleans

References

Ghali JK, Orlov MV, Araghi-Niknam M, Sherfesee L, Hettrick DA. The influence of symptoms and device detected atrial tachyarrhythmias on medical management: insights from A-HIRATE. Pacing Clin Electrophysiol. 2007 Jul;30(7):850-7.

Citations Reporting on Results

Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol. 2007 Mar;30(3):404-11.

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