- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01694550
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
-
-
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Magdeburg, Germany, 39120
- Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie
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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 |
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Pacemaker mode programming
High grade AV-block
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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
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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