Mechanisms and Innovations in Cardiac Resynchronisation Therapy

Heart Failure Clinical Trial

— MIC  

Official title:

Evaluation of Mechanisms and Innovations in Cardiac Resynchronization Therapy

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
• 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
• 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

Related Conditions & MeSH terms

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

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