The Effects of Selective Site Right Ventricular Pacing

Bradycardia Clinical Trial

— PacingRV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153242
• Other study ID #: B596
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bradycardia

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