Status:
COMPLETED
The Atrial High Rate Episodes in Pacemaker Patients
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Arrhythmia
Atrial Fibrillation
Eligibility:
All Genders
50+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT00627328
Start Date
July 1 2000
End Date
September 1 2004
Last Update
March 3 2008
Active Locations (42)
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1
Hot Springs, Arkansas, United States
2
Little Rock, Arkansas, United States
3
Fresno, California, United States
4
Glendale, California, United States