The Atrial High Rate Episodes in Pacemaker Patients

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627328
• Other study ID #: 163
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: February 22, 2008
• Start date: July 2000
• Est. completion date: September 2004

Study information

• Verified date: February 2008
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEuropean Union: European Medicines AgencyAustralia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Atrioventricular Block
• Bradycardia
• Sick Sinus Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Australia,  France, 

References & Publications (2)

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. — View Citation

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 Cli — View Citation