Mechanisms and Innovations in Cardiac Resynchronisation Therapy

NCT04221763 | Completed DMC FDA Device

• 2 other identifiers: 18HH4801FS/19/4/34013
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Conduction system battery longevity

  6 weeks, 3 months, 6 months, 12 months.

• Conduction system lead threshold

  6 weeks, 3 months, 6 months, 12 months.

• Heart failure symptoms

  6 months

• Left ventricular ejection fraction

  12 months

• Cardiopulmonary exercise testing

  6 months

Study Arms (1)

Heart failure and abnormal cardiac conduction

EXPERIMENTAL

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.

Device: His-bundle pacing.

Interventions

His-bundle pacing. 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.

Also known as: Left bundle pacing, Biventricular pacing, Combined His-bundle and left ventricular epicardial pacing (HOT-CRT)

Heart failure and abnormal cardiac conduction

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give consent
• Children (age \< 18 years)
• Pregnant women

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital Imperial College NHS trust

London, W12 0HS, United Kingdom

Location

Related 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.

  PMID: 23900696 BACKGROUND

• 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.

  PMID: 30681348 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction, Left; Bundle-Branch Block

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Zachary Whinnett, BM BS B

  Imperial College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: January 9, 2020
• Study Start: October 15, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: 3 years
• Access Criteria: Medtronic will only have access to anonymised data in the form of non-invasive electrical maps (ECGi, CardioInsight)

Locations

GB (1)