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Completed

NCT Number: NCT02153242

The Effects of Selective Site 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ventricular Function

    Time frame: 30 minutes

    Measurement of both right and left ventricular function under differing pacing conditions

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: PacingRV

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2014
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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