QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY)
Verified September 2012 by University of Magdeburg
Information provided by (Responsible Party):
Dr. Samir Said, University of Magdeburg
First received: September 24, 2012
Last updated: September 28, 2012
Last verified: September 2012
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.
High Degree AV-block
Left Bundle Branch Block
||Observational Model: Cohort
Time Perspective: Prospective
||Corrected QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY-Study)
Biospecimen Retention: None Retained
No biospecimen are necessary for the study and this issue is irrelevant.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2015 (Final data collection date for primary outcome measure)
Pacemaker mode programming
High grade AV-block
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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694550
|Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie
|Magdeburg, Germany, 39120 |
|Contact: Samir Said, Dr. +49 391 6713203 firstname.lastname@example.org |
|Contact: Thomas P Rauwolf, Dr. +49 391 6713203 email@example.com |
University of Magdeburg
||Samir Said, Dr.
No publications provided
||Dr. Samir Said, Dr. med., University of Magdeburg
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2012
||September 28, 2012
||Germany: Ethics Commission
Keywords provided by University of Magdeburg:
ICD / CRTD
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 26, 2014