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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153242
Other study ID # B596
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2013
Est. completion date June 2015

Study information

Verified date December 2020
Source Mid and South Essex NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom The Essex Cardiothoracic Centre Basildon Essex

Sponsors (1)

Lead Sponsor Collaborator
Mid and South Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ventricular Function Measurement of both right and left ventricular function under differing pacing conditions 30 minutes
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