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The Effects of Selective Site Right Ventricular Pacing (PacingRV)

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ClinicalTrials.gov Identifier: NCT02153242
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : April 11, 2016
Sponsor:
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 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.


Condition or disease
Bradycardia

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.


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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Does a Surrogate Marker Exist That Can be Used as A Predictor For Left Ventricular Dysfunction In Patients Undergoing Right Ventricular Pacing
Study Start Date : September 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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



Primary Outcome Measures :
  1. Ventricular Function [ Time Frame: 30 minutes ]
    Measurement of both right and left ventricular function under differing pacing conditions



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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:   Non-Probability Sample
Study Population
Patients undergoing SVT studies
Criteria

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

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): NCT02153242


Locations
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United Kingdom
Basildon & Thurrock University Hospital NHS Trust
Basildon, Essex, United Kingdom, SS16 5NL
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Stuart Tan Basildon & Thurrock University Hospital NHS Trust

Study Data/Documents: Poster Contribution  This link exits the ClinicalTrials.gov site
Identifier: A449

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Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02153242     History of Changes
Other Study ID Numbers: B596
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
Pacing
Haemodynamics
Pilot
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes