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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00627328




Registration number
NCT00627328
Ethics application status
Date submitted
26/12/2007
Date registered
3/03/2008
Date last updated
3/03/2008

Titles & IDs
Public title
The Atrial High Rate Episodes in Pacemaker Patients
Scientific title
The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients
Secondary ID [1] 0 0
163
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmia 0 0
Atrial Fibrillation 0 0
Atrioventricular Block 0 0
Bradycardia 0 0
Sick Sinus Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - pacemaker patients with previously diagnosed AT.

2 - pacemaker patients without previously diagnosed AT.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2004
Sample size
Target
Accrual to date
Final
427
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Ashford
Recruitment hospital [2] 0 0
- Ballarat
Recruitment hospital [3] 0 0
- Bedford Park
Recruitment postcode(s) [1] 0 0
- Ashford
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Indiana
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United States of America
State/province [5] 0 0
Kentucky
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United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
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United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Rouen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.
Trial website
https://clinicaltrials.gov/study/NCT00627328
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
M. V. Orlov, MD
Address 0 0
Tufts University School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00627328