Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot

NCT02198781 | Completed

• 1 other identifier: B729
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Sick Sinus Syndrome

Keywords

atrial fibrilation; atrial-ventricula; right ventricle; left ventricle; surrogate marker; ventricular dysfunction; pacing

Outcome Measures

Primary Outcomes (1)

• surrogate marker

  To identify any surrogate markers for this patient cohort

  30 minutes

Secondary Outcomes (1)

• dyssynchronous index

  30 minutes

Study Arms (1)

Cohort

Basic science study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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%)

You may not qualify if:

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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Anglia Ruskin University: collaborator

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Ventricular Dysfunction

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart Tan, MB BC, MRCP

  Mid and South Essex NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 24, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

GB (1)