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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04221763
Other study ID # 18HH4801
Secondary ID FS/19/4/34013
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date December 1, 2022

Study information

Verified date March 2023
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients referred for conventional CRT - Severe heart failure (LVEF, a measure of heart pumping, < 35% - severe) - Prolonged QRS duration (>120ms) - Adults willing to take part (age > 18 years) - Able to give consent Exclusion Criteria: - Unable to give consent - Children (age < 18 years) - Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom Hammersmith Hospital Imperial College NHS trust London

Sponsors (1)

Lead Sponsor Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29. — View Citation

Vijayaraman P, Herweg B, Ellenbogen KA, Gajek J. His-Optimized Cardiac Resynchronization Therapy to Maximize Electrical Resynchronization: A Feasibility Study. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006934. doi: 10.1161/CIRCEP.118.006934. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acute change is systolic blood pressure Mean change in systolic blood pressure (mmHg) from atrial pacing to AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in mmHg. 20 minutes
Primary Acute electrical measurements Mean change in left ventricular activation time (Milliseconds) (measured using ECGI) during AV sequential CRT pacing (HBP, LBP, epiBVP and combined HPB with epiLVP) at optimal AV delay measured in Milliseconds. 20 minutes
Secondary Conduction system battery longevity The measurements include battery longevity measured in months. 6 weeks, 3 months, 6 months, 12 months.
Secondary Conduction system lead threshold The measurements include lead threshold to achieved QRS narrowing measured in Volts at 0.5ms and 1ms. 6 weeks, 3 months, 6 months, 12 months.
Secondary Heart failure symptoms Heart failure symptoms of patients with permanent conduction system leads will be assessed at follow up at 3 month, 6 months and 12 months. The symptoms will be assessed using the Minnesota living with heart failure questionnaire score. 6 months
Secondary Left ventricular ejection fraction Patients with permanent conduction system leads will undergo a repeat echocardiography and measure their left ventricular ejection fraction. 12 months
Secondary Cardiopulmonary exercise testing Patients with permanent conduction system leads will undergo symptom assessment with a repeat cardio-pulmonary exercise test to measure MVO2 in litres/minute. 6 months
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