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Completed

NCT Number: NCT01694550

QT Interval in Patients With Pacemaker Dependency

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.

Completed

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Key information

Conditions

High Degree AV-block Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Left Bundle Branch Block Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie

Magdeburg, 39120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Corrected QT Interval in Patients With Pacemaker Dependency

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Registry information

Official study title

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

Acronym: QT-TENDENCY

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Sep 27, 2012
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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