QT Interval in Patients With Pacemaker Dependency

Left Bundle Branch Block Clinical Trial

— QT-TENDENCY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694550
• Other study ID #: OVGU-Kar-011
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: October 27, 2016
• Start date: March 2012
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bundle-Branch Block
• High Degree AV-block
• Left Bundle Branch Block

Locations

Country	Name	City	State
Germany	Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected QT Interval in Patients With Pacemaker Dependency		baseline	No