The Atrial High Rate Episodes in Pacemaker Patients

Completed

• Conditions: Arrhythmia; Atrial Fibrillation; Atrioventricular Block; Bradycardia; Sick Sinus Syndrome

• Registration Number: NCT00627328
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-07
• Study Completion: 2004-09
• Study First Submitted: 2007-12-26
• Status Verified: 2008-02
• Study First Submitted QC: 2008-02-22
• Last Update Submitted: 2008-02-22
• Study First Posted: 2008-03-03
• Last Update Posted: 2008-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified