The Atrial High Rate Episodes in Pacemaker Patients

This study has been completed.

First Received on December 26, 2007. Last Updated on February 22, 2008 History of Changes

Sponsor:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00627328

Purpose

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

Condition
Arrhythmia Atrial Fibrillation Atrioventricular Block Bradycardia Sick Sinus Syndrome

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Enrollment:	427
Study Start Date:	July 2000
Study Completion Date:	September 2004

Groups/Cohorts
1 pacemaker patients with previously diagnosed AT.
2 pacemaker patients 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Prospective study with patients undergoing a Medtronic Kappa DR 700 or Medtronic Kappa 900 DR implant, for approved indications.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627328

Show 42 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Principal Investigator:	M. V. Orlov, MD	Tufts University School of Medicine
Principal Investigator:	J.K. Ghali, MD	Louisiana State University Health Sciences Center in New Orleans

More Information

Publications:

Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; for the 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.

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.

Responsible Party:	Diane Sahr, CRDM Clincial Research
ClinicalTrials.gov Identifier:	NCT00627328 History of Changes
Other Study ID Numbers:	163
Study First Received:	December 26, 2007
Last Updated:	February 22, 2008
Health Authority:	United States: Institutional Review Board; European Union: European Medicines Agency; Australia: Human Research Ethics Committee

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Physiologic Pacing
Dual Chamber Pacing
Atrioventricular Block
Bradycardia
Sick Sinus Syndrome

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Atrial Fibrillation
Atrioventricular Block
Sick Sinus Syndrome
Bradycardia

Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Block
Arrhythmia, Sinus

ClinicalTrials.gov processed this record on February 09, 2012