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Heart FailureMICNCT04221763

Mechanisms and Innovations in Cardiac Resynchronisation Therapy

A study testing His-bundle pacing. in people with Heart Failure and Left Ventricular Systolic Dysfunction, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
His-bundle pacing.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteUnited Kingdom
Study dates
15 Oct 2019to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hammersmith Hospital Imperial College NHS trust

    London, W12 0HS

Other trials in United Kingdom

About this study

Official title: Evaluation of Mechanisms and Innovations in Cardiac Resynchronization Therapy

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.

Read the 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.

Being tested
His-bundle pacing.
Keywords
Cardiac resynchronization therapy, His bundle pacing, Haemodynamics, ECGI
Medical subject headings
Heart Failure, Ventricular Dysfunction, Left, Bundle-Branch Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • His-bundle pacing.Device

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

    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.

Study groups in NCT04221763
Study groupRoleWhat they receive
Heart failure and abnormal cardiac conductionExperimentalSubjects 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.
Receives: Device: His-bundle pacing.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 20 minutes

  2. 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.

    Measured: 20 minutes

Secondary outcomes (5)

  1. Conduction system battery longevity

    The measurements include battery longevity measured in months.

    Measured: 6 weeks, 3 months, 6 months, 12 months.

  2. Conduction system lead threshold

    The measurements include lead threshold to achieved QRS narrowing measured in Volts at 0.5ms and 1ms.

    Measured: 6 weeks, 3 months, 6 months, 12 months.

  3. 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.

    Measured: 6 months

  4. Left ventricular ejection fraction

    Patients with permanent conduction system leads will undergo a repeat echocardiography and measure their left ventricular ejection fraction.

    Measured: 12 months

  5. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2020
  2. Study start15 Oct 2019
  3. Primary completion1 Dec 2022
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04221763
Sponsor's protocol ID
18HH4801
Other IDs
FS/19/4/34013
Acronym
MIC
Status last verified
Mar 2023
First submitted
4 Nov 2019
Last updated
22 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: We plan to share the electrical data obtained from non-invasive electrical mapping with Medtronic (industry company)

Publications

  • 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.

    PubMed 23900696

  • 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.

    PubMed 30681348

Questions about this trial

What is this clinical trial studying?

A study testing His-bundle pacing. in people with Heart Failure and Left Ventricular Systolic Dysfunction, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute change is systolic blood pressure (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04221763, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.

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