Clinical trial NCT04221763: Mechanisms and Innovations in Cardiac Resynchronisation Therapy
Official title: Evaluation of Mechanisms and Innovations in Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Left Ventricular Systolic Dysfunction
Left Bundle-Branch Block
Right Bundle-Branch Block
Non-Specific Intraventricular Conduction Defect
Keywords: Cardiac resynchronization therapy
His bundle pacing
Haemodynamics
ECGI
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 60 patients with heart failure, severe left ventricular systolic dysfunction and cardiac conduction abnormality (QRS \> 120ms) will be recruited and undergo an attempt at His bundle, left bundle pacing and biventricular pacing. Patients will have acute haemodynamic and electrical measurements.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute change is systolic blood pressure
timeFrame: 20 minutes
measure: Acute electrical measurements
timeFrame: 20 minutes
Secondary outcomes:
measure: Conduction system battery longevity
timeFrame: 6 weeks, 3 months, 6 months, 12 months.
measure: Conduction system lead threshold
timeFrame: 6 weeks, 3 months, 6 months, 12 months.
measure: Heart failure symptoms
timeFrame: 6 months
measure: Left ventricular ejection fraction
timeFrame: 12 months
measure: Cardiopulmonary exercise testing
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital Imperial College NHS trust
Study officials:
affiliation: Imperial College London
name: Zachary Whinnett, BM BS B
role: STUDY_CHAIR
References:
citation: 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.
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.