The Effects of Selective Site Right Ventricular Pacing (PacingRV)

December 21, 2020 updated by: Mid and South Essex NHS Foundation Trust

Does a Surrogate Marker Exist That Can be Used as A Predictor For Left Ventricular Dysfunction In Patients Undergoing Right Ventricular Pacing

This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population with structurally normal hearts. The investigators aim to measure heart function directly when pacing.

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. The usual site for pacing is the tip of the RV. This has been shown to be less efficient than the normal conduction system of the heart and in some cases leads to markedly reduced function. What the investigators do not know is why this is the case.

Much effort has been directed at looking at features within the left ventricle (LV) for markers of disease progression but little has been investigated regarding the RV.

There may be some benefit to pacing the heart preferentially from different parts of the RV and the investigators aim to measure if any differences are detectable from stimulating the heart at various sites within the RV.

Study Overview

Status

Completed

Conditions

Detailed Description

Inclusion Criteria;

  • Patients undergoing elective Electrophysiological Studies +/Ablation
  • Age 18-80
  • Normal Heart on Pre-procedural Echocardiogram

Exclusion criteria;

  • Atrial Fibrillation
  • Evidence of anterograde conducting accessory pathway
  • Permanent Pacemaker insitu
  • Pregnant
  • Breast Feeding

Outcome Measures; Change in load-independent indices of LV and RV contractility before and after pacing intervention. LV and RV function measured by transthoracic echocardiography and tissue Doppler imaging.

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • The Essex Cardiothoracic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing SVT studies

Description

Inclusion Criteria:

  • Patients undergoing elective Electrophysiological Studies +/Ablation
  • Age 18-80
  • Normal Heart on Pre-procedural Echocardiogram

Exclusion criteria:

  • Atrial Fibrillation
  • Evidence of anterograde conducting accessory pathway
  • Permanent Pacemaker insitu
  • Pregnant
  • Breast Feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Supra Ventricular Tachycardia (SVT)
Patients undergoing SVT studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular Function
Time Frame: 30 minutes
Measurement of both right and left ventricular function under differing pacing conditions
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid and South Essex NHS Foundation Trust

Investigators

  • Principal Investigator: Stuart Tan, Basildon & Thurrock University Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bradycardia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe