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

October 27, 2016 updated by: Dr. Samir Said, University of Magdeburg

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Magdeburg, Germany, 39120
        • Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pacemaker mode programming
High grade AV-block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corrected QT Interval in Patients With Pacemaker Dependency
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Investigators

  • Principal Investigator: Samir Said, Dr., Magdeburg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVGU-Kar-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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