QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY)

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. Identifier: NCT01694550
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : October 28, 2016
Information provided by (Responsible Party):
Dr. Samir Said, University of Magdeburg

Brief Summary:
The aim of this study is to examine a correction term for an adapted QT interval during ventricular pacing (right, left and biventricular pacing) to obtain valid formulae correcting for the QT intervals in various pacing conditions.

Condition or disease
High Degree AV-block Left Bundle Branch Block

Detailed Description:
This investigation aims at determining a possibility to assess the usefulness of various formulae that correct for the different effects of various pacing modes on the QT interval. More specifically, the hypothesis will be tested that applying adequate correction will preserve the predictive power of the QT-interval regarding proarrhythmia in various cardiac pathologies and therapies.

Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Corrected QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY-Study)
Study Start Date : March 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Pacemaker mode programming
High grade AV-block

Primary Outcome Measures :
  1. Corrected QT Interval in Patients With Pacemaker Dependency [ Time Frame: baseline ]

Biospecimen Retention:   None Retained
No biospecimen are necessary for the study and this issue is irrelevant.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll 180 patients after an implantation of cardioverter/defibrillator or pacemaker based on a standard guideline indication. The point of enrolment for all patients is the time at which the patient signs and dates the ICF during the hospital stay in the context of implantation.

Inclusion Criteria:

  • caucasian race
  • implanted cardioverter/defibrillator or pacemaker
  • negative pregnancy test for women of child bearing potential
  • stable function of the implanted device
  • stable medical therapy relating to the underlying disease
  • stable medical therapy of antiarrhythmic drugs and other QT-time changing drugs
  • no instability of rhythm
  • x-ray of thorax during device implantation in two levels (ap and ll axis)
  • written informed consent

Exclusion Criteria:

  • coronary heart disease and angina pectoris symptoms
  • patient with acute myocardial infarction or CABG while the last 4 weeks
  • patient with tachycardia and a rest frequency >80 bpm
  • patient with severe pulmonary disease
  • patient with anaemia
  • patient with acute infections
  • patient with severe kidney or liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01694550

Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
Principal Investigator: Samir Said, Dr. Magdeburg University

Responsible Party: Dr. Samir Said, Dr. med., University of Magdeburg Identifier: NCT01694550     History of Changes
Other Study ID Numbers: OVGU-Kar-011
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

Keywords provided by Dr. Samir Said, University of Magdeburg:
corrected QT-interval

Additional relevant MeSH terms:
Bundle-Branch Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes