Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
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|ClinicalTrials.gov Identifier: NCT02198781|
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : December 6, 2016
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population who are clinically indicated to receive a pacemaker.
When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat.
Increasingly the available evidence suggests that long term RV pacing is associated with complications - left ventricule (LV) dysfunction, heart failure, atrial fibrillation (AF) and death in some patients. What we do not see are a large proportion of all patients who receive pacemakers suffering pacing related adverse effects.
If there could be a way of identifying those patients in the group who go on to develop pacing induced cardiomyopathy at the time of initial pacing implant, this would be a very valuable clinical measure. These patients could be identified from the outset and paced with a biventricular device to avoid the pacing induced cardiomyopathy. Whilst much energy has been directed towards the LV as a focus of the clinical markers of disease, little has been published looking at RV haemodynamics.
We plan to study a cohort of patients who are clinically indicated to receive a pacemaker and study their RV in detail at the time of implantation. We will use conductance catheters and echocardiography to determine measures of pumping function. We will then follow them up for a period of six month using echocardiography and blood markers of heart dysfunction. In those patients who have a reduction in heart function we will then look for common patterns within their initial measurements.
|Condition or disease|
|Sick Sinus Syndrome|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Does a Measure Exist in the Right Ventricle Which Can Act as a Surrogate Marker for Future Ventriclar Sysfunction When Pacing - a Pilot Study|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Basic science study
- surrogate marker [ Time Frame: 30 minutes ]To identify any surrogate markers for this patient cohort
- dyssynchronous index [ Time Frame: 30 minutes ]To identify if any dyssynchronour index can be obtained in the right ventricle in this cohort
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198781
|Basildon and Thurrock University Hospitals NHS Foundation Trust|
|Basildon, Essex, United Kingdom, SS16 5NL|
|Principal Investigator:||Stuart Tan, MB BC, MRCP||Basildon and Thurrock University Hospitals NHS Foundation Trust|