Mechanisms and Innovations in Cardiac Resynchronisation Therapy

NCT ID: NCT04221763

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2022-12-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heart failure and abnormal cardiac conduction

Subjects will have an attempt at His-bundle pacing, left bundle pacing and biventricular pacing. Pacing at the His bundle and the left bundle will be attempted using a Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Biventricular pacing will utilise a left ventricular lead placed in the coronary sinus using any of the 5 manufactures of CS leads Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical or in participants receiving permanent conduction system pacing left ventricular pacing will be achieved using a Cordis ATW™ wire placed in the coronary sinus.

Group Type: EXPERIMENTAL

His-bundle pacing.

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Left bundle pacing; Biventricular pacing; Combined His-bundle and left ventricular epicardial pacing (HOT-CRT)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zachary Whinnett, BM BS B

Role: STUDY_CHAIR

Imperial College London

Locations

Hammersmith Hospital Imperial College NHS trust

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 23900696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30681348 (View on PubMed)

Other Identifiers

FS/19/4/34013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

18HH4801

Identifier Type: -

Identifier Source: org_study_id