NCT02153242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

May 6, 2014

Last Update Submit

December 21, 2020

Conditions

Keywords

PacingHaemodynamicsPilot

Outcome Measures

Primary Outcomes (1)

  • Ventricular Function

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

    30 minutes

Study Arms (1)

Supra Ventricular Tachycardia (SVT)

Patients undergoing SVT studies

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing SVT studies

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stuart Tan

    Basildon & Thurrock University Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

June 3, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations