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Effects Rapid Atrial Pacing Has on the Electrocardiogram (ECG) in Patients With Dual Chamber Pacemakers

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ClinicalTrials.gov Identifier: NCT00883610
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : December 11, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Dawood Darbar, Vanderbilt University

April 16, 2009
April 17, 2009
December 11, 2014
April 2009
June 2012   (Final data collection date for primary outcome measure)
Determine the effect of abrupt changes in atrial rate on QT intervals [ Time Frame: 7 days ]
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Complete list of historical versions of study NCT00883610 on ClinicalTrials.gov Archive Site
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Effects Rapid Atrial Pacing Has on the Electrocardiogram (ECG) in Patients With Dual Chamber Pacemakers
Modulation of QT Interval by Rapid Atrial Pacing in Patients With Dual Chamber Pacemakers
The purpose of this study is to learn what effect rapid atrial pacing (in patients with dual chamber pacemakers) will have on the electrocardiogram including the QT Interval. The investigators are also interested in the differences caused by genes.

This study requires a total of two study days as well as two follow up visits. During study day one, baseline blood will be drawn, a baseline electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. The pacemaker rate will be increased to 90bpm at different time intervals and additional blood will be drawn to measure the effects of these rates changes.

On study day two, baseline blood will be drawn, a urine specimen will be obtained, an electrocardiogram will be performed, and continuous QT Interval monitoring will be performed. Following the acquisition of this information, the pacemaker rate will be decreased to 80bpm. We will obtain blood specimens, a urine specimen and an electrocardiogram at 30 minutes post rate change and again at 60 minutes post rate change.

Two days following the rate decrease to 80bpm, the patient will return to clinic to have their rate decreased to 70bpm. In two more days, the patient will return for a final rate change to 60bpm.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Cardiology Clinic
Prolonged QT Interval
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
50
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be at least 21 years old
  • Must have a dual chamber pacemaker implanted more than three months ago
  • Must be followed by the Vanderbilt University Medical Center's Arrhythmia Device Clinic
  • The indication for the pacemaker must not be related to coronary artery disease (CAD) or congestive heart failure (CHF)

Exclusion Criteria:

  • Cannot be pacemaker dependent
  • History of ventricular arrhythmias and/or implantable defibrillators (ICDs)
  • History of paroxysmal, persistent, or permanent atrial fibrillation (AF)
  • Congenital long QT syndrome
  • History of coronary artery disease
  • History of, or currently receiving, treatment for congestive heart failure
  • Unable to tolerate dual-chamber pacing (DDD) at 90 bpm due to palpitations, chest pain, shortness of breath, lightheadedness, dizziness, or presyncope
  • Pregnant women
  • Any patient without specific documentation of an echocardiogram negative for CHF (systolic or diastolic dysfunction)within five years prior to study enrollment
  • Any patient without specific documentation of an objective diagnostic test to rule out CAD within five years prior to study enrollment
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00883610
070070
Yes
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Dawood Darbar, Vanderbilt University
Vanderbilt University
  • National Institutes of Health (NIH)
  • Wake Forest University Health Sciences
Principal Investigator: Dawood Darbar, M.D., Ph.D., F.A.C.C. Vanderbilt University Medical Center
Vanderbilt University
December 2014