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The Atrial High Rate Episodes in Pacemaker Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00627328
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : March 3, 2008
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date December 26, 2007
First Posted Date March 3, 2008
Last Update Posted Date March 3, 2008
Study Start Date July 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Atrial High Rate Episodes in Pacemaker Patients
Official Title The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Arrhythmia
  • Atrial Fibrillation
  • Atrioventricular Block
  • Bradycardia
  • Sick Sinus Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 1
    pacemaker patients with previously diagnosed AT.
  • 2
    pacemaker patients without previously diagnosed AT.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February¬†22,¬†2008)
427
Original Actual Enrollment Same as current
Actual Study Completion Date September 2004
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00627328
Other Study ID Numbers 163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Diane Sahr, CRDM Clincial Research
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Not Provided
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
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date February 2008