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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Magdeburg
Sponsor:
Information provided by (Responsible Party):
Dr. Samir Said, University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01694550
First received: September 24, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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
High Degree AV-block
Left Bundle Branch Block

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Corrected QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY-Study)

Further study details as provided by University of Magdeburg:

Biospecimen Retention:   None Retained

No biospecimen are necessary for the study and this issue is irrelevant.


Estimated Enrollment: 180
Study Start Date: March 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pacemaker mode programming
High grade AV-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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694550

Contacts
Contact: Samir Said, Dr. +49 391 6713203 samir.said@med.ovgu.de
Contact: Thomas P Rauwolf, Dr. +49 391 6713203 thomas.rauwolf@med.ovgu.de

Locations
Germany
Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie Recruiting
Magdeburg, Germany, 39120
Contact: Samir Said, Dr.    +49 391 6713203    samir.said@med.ovgu.de   
Contact: Thomas P Rauwolf, Dr.    +49 391 6713203    thomas.rauwolf@med.ovgu.de   
Sponsors and Collaborators
University of Magdeburg
Investigators
Principal Investigator: Samir Said, Dr. Magdeburg University
  More Information

No publications provided

Responsible Party: Dr. Samir Said, Dr. med., University of Magdeburg
ClinicalTrials.gov Identifier: NCT01694550     History of Changes
Other Study ID Numbers: OVGU-Kar-011
Study First Received: September 24, 2012
Last Updated: September 28, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Magdeburg:
pacemaker
ICD / CRTD
corrected QT-interval

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

ClinicalTrials.gov processed this record on October 28, 2014