QT Interval in Patients With Pacemaker Dependency

NCT ID: NCT01694550

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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High Degree AV-block Left Bundle Branch Block

Keywords

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pacemaker ICD / CRTD corrected QT-interval

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pacemaker mode programming

High grade AV-block

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Dr. Samir Said

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samir Said, Dr.

Role: PRINCIPAL_INVESTIGATOR

Magdeburg University

Locations

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Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie

Magdeburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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OVGU-Kar-011

Identifier Type: -

Identifier Source: org_study_id