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The Atrial High Rate Episodes in Pacemaker Patients

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00627328
First received: December 26, 2007
Last updated: February 22, 2008
Last verified: February 2008
History of Changes
  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:

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:

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 May 21, 2013