Clinical trial NCT00627328: The Atrial High Rate Episodes in Pacemaker Patients
Official title: The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
Atrial Fibrillation
Atrioventricular Block
Bradycardia
Sick Sinus Syndrome
Keywords: Physiologic Pacing
Dual Chamber Pacing
Atrioventricular Block
Bradycardia
Sick Sinus Syndrome
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2008-03-03
Enrollment: 427
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: Glendale
country: United States
state: California
city: San Diego
country: United States
state: California
city: Daytona Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Hammond
country: United States
state: Indiana
city: Hobart
country: United States
state: Indiana
city: Munster
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Marrero
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Salisbury
country: United States
state: Maryland
city: West Roxbury
country: United States
state: Massachusetts
city: St. Cloud
country: United States
state: Minnesota
city: Livingston
country: United States
state: New Jersey
city: Patterson
country: United States
state: New Jersey
city: Bronx,
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Gastonia
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Willimington
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Bethlehem
country: United States
state: Pennsylvania
city: Mechanicsburg
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Chattanooga
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Ashford
country: Australia
city: Ballarat
country: Australia
city: Bedford Park
country: Australia
city: Lille
country: France
city: Rouen
country: France
Study officials:
affiliation: Tufts University School of Medicine
name: M. V. Orlov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: J.K. Ghali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1540-8159.2007.00772.x.
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 Clin Electrophysiol. 2007 Mar;30(3):404-11. doi: 10.1111/j.1540-8159.2007.00682.x.