NCT04221763

Mechanisms and Innovations in Cardiac Resynchronisation Therapy

Evaluation of Mechanisms and Innovations in Cardiac Resynchronization Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the effectiveness of multiple modalities of cardiac resynchronisation therapy using high precision acute electrical and haemodynamic measurements.These modalities include biventricular pacing and conduction system pacing utilising His bundle and left bundle pacing. Conduction system pacing is a more physiological form of pacing. The study hypothesises that this will produce more effective cardiac resynchronisation.

Detailed description

This is a single centre acute electrical/haemodynamic and observational study of a subgroup of patients with heart failure. A total of 60 will be recruited. The acute study involves within patient comparison of biventricular and conduction system pacing using detailed electrical mapping and high precision haemodynamic measurement protocol. Participants will have permanent conduction system pacing if; * Baseline left bundle branch block and QRS \> 140ms or QRS \>150ms and any QRS morphology AND * Conduction system pacing is successful at reducing QRS duration by 20ms or more with satisfactory pacing parameters. Participants who receive permanent conduction system pacing will have follow up at 6 weeks, 3 months, 6 months and 12 months. Non-invasive markers including mechanical activation pattern (echocardiography and cardiac MRI) and electrical activation pattern (ultra-high frequency electrocardiography) will be used to identify the characteristics of patients who benefit from conduction system pacing.

Conditions

• Heart Failure
• Left Ventricular Systolic Dysfunction
• Left Bundle-Branch Block
• Right Bundle-Branch Block
• Non-Specific Intraventricular Conduction Defect

Interventions

Type	Name	Description
DEVICE	His-bundle pacing.	Cardiac resynchronisation therapy can be achieved using biventricular pacing involving placement of three leads into the right atrium, right ventricle and coronary sinus (epicardial left ventricle). Alternatively the third lead may be placed at the bundle of His or left ventricular septum to pace the left bundle directly.

Timeline

• Start date: 2019-10-15
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-01-09
• Last updated: 2023-03-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study