High Degree AV-blockQT-TENDENCYNCT01694550
QT Interval in Patients With Pacemaker Dependency
An observational study of High Degree AV-block and Left Bundle Branch Block, run by University of Magdeburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High Degree AV-block, Left Bundle Branch Block
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- no instability of rhythm
- x-ray of thorax during device implantation in two levels (ap and ll axis)
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Magdeburg University, Internal Medicine/Cardiology, Angiology and Pneumologie
Magdeburg, 39120
About this study
Official title: 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.
Read the 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.
- Conditions
- High Degree AV-block, Left Bundle Branch Block
- Keywords
- pacemaker, ICD / CRTD, corrected QT-interval
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker mode programming | High grade AV-block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected QT Interval in Patients With Pacemaker Dependency
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Degree AV-blockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Samir Said, University of Magdeburg
- Investigators
- Samir Said, Dr., Principal investigator, Magdeburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694550
- Sponsor's protocol ID
- OVGU-Kar-011
- Acronym
- QT-TENDENCY
- Status last verified
- Oct 2016
- First submitted
- 24 Sep 2012
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrected QT Interval in Patients With Pacemaker Dependency (QT-TENDENCY-Study)
- ClinicalTrials.gov ID
- NCT01694550
- Acronym / sponsor ID
- QT-TENDENCY / OVGU-Kar-011
- Conditions
- High Degree AV-block, Left Bundle Branch Block
- Keywords
- pacemaker, ICD / CRTD, corrected QT-interval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacemaker mode programming | – | –High grade AV-block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corrected QT Interval in Patients With Pacemaker Dependency
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Said, Dr. principal investigator
Magdeburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Degree AV-block and Left Bundle Branch Block, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected QT Interval in Patients With Pacemaker Dependency (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.