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Trial record 8 of 62 for:    "Sick Sinus Syndrome"

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
Sponsor:
Collaborator:
Anglia Ruskin University
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals NHS Foundation Trust

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort
Basic science study



Primary Outcome Measures :
  1. surrogate marker [ Time Frame: 30 minutes ]
    To identify any surrogate markers for this patient cohort


Secondary Outcome Measures :
  1. dyssynchronous index [ Time Frame: 30 minutes ]
    To identify if any dyssynchronour index can be obtained in the right ventricle in this cohort



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are due to undergo permanent pacemaker (PPM) implantation will be recruited to undergo RV Pressure/Volume loop assessment and RV strain ECHO at the same time as PPM implant for pilot data regarding the acute effects of RV pacing on RV haemodynamics
Criteria

Inclusion Criteria:

  • Patient undergoing permanent pacemaker (PPM) implantation
  • Age 18-80 years old
  • High grade atrial-ventricular (AV) block
  • Preserved left ventricle (LV) systolic function on pre-procedure Echocardiogram (EF>45%)

Exclusion Criteria:

  • Atrial Fibrillation
  • Recent myocardial infarct (MI)
  • Pregnancy
  • Enrolment in any other study
  • Inability or refusal to comply with the follow-up schedule

Information from the National Library of Medicine

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


Locations
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United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, Essex, United Kingdom, SS16 5NL
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Anglia Ruskin University
Investigators
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Principal Investigator: Stuart Tan, MB BC, MRCP Basildon and Thurrock University Hospitals NHS Foundation Trust

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Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02198781     History of Changes
Other Study ID Numbers: B729
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
atrial fibrilation
atrial-ventricula
right ventricle
left ventricle
surrogate marker
ventricular dysfunction
pacing
Additional relevant MeSH terms:
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Ventricular Dysfunction
Sick Sinus Syndrome
Heart Diseases
Cardiovascular Diseases
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Block
Cardiac Conduction System Disease
Pathologic Processes