Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 41 of 75 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

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

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: 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

Tracking Information
First Submitted Date April 16, 2009
First Posted Date April 17, 2009
Last Update Posted Date December 11, 2014
Study Start Date April 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2013)
Determine the effect of abrupt changes in atrial rate on QT intervals [ Time Frame: 7 days ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00883610 on ClinicalTrials.gov Archive Site
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 Effects Rapid Atrial Pacing Has on the Electrocardiogram (ECG) in Patients With Dual Chamber Pacemakers
Official Title Modulation of QT Interval by Rapid Atrial Pacing in Patients With Dual Chamber Pacemakers
Brief Summary 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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cardiology Clinic
Condition Prolonged QT Interval
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   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: April 10, 2013)
12
Original Estimated Enrollment
 (submitted: April 16, 2009)
50
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00883610
Other Study ID Numbers 070070
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dawood Darbar, Vanderbilt University
Study Sponsor Vanderbilt University
Collaborators
  • National Institutes of Health (NIH)
  • Wake Forest University Health Sciences
Investigators
Principal Investigator: Dawood Darbar, M.D., Ph.D., F.A.C.C. Vanderbilt University Medical Center
PRS Account Vanderbilt University
Verification Date December 2014