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Heart FailureNCT05814263

HIS Alternative II - UK Site

A study testing HIS/LBB pacing and LV pacing in people with Heart Failure and Left Bundle-Branch Block, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Left Bundle-Branch Block
What is being tested?
HIS/LBB pacing and LV pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
1 Dec 2023to 1 Jan 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF ≤ 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and
  • Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below)
  • Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment
  • Signed informed consent
  • Typical left bundle branch block:
  • QRS width > 130 msec for women and > 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL

Who cannot join

  • Existing biventricular pacing system
  • Permanent atrial fibrillation
  • Severe renal failure with eGFR < 30 ml/min
  • AMI or CABG within the last three months
  • The patient does not want to participate

Trial locations and contacts

1 site in 1 country.

Daniel Keene, MBChB contact

020 3313 1000

daniel.keene@nhs.net

mohamed zuhair, MBBS contact

020 3313 1000

m.zuhair@nhs.net

United Kingdom1 site, 1 recruiting

  • Hammersmith Hospital

    London

    Daniel Keene

    Recruiting

Other trials in United Kingdom

About this study

Official title: Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With Symptomatic Heart Failure Despite Optimal Medical Treatment and ECG With Typical Left Bundle Branch Block

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.

Read the detailed description

Biventricular pacing has for more than a decade been standard of care for patients with HFrEF, LVEF < 35%, NYHA II-IV despite optimal medical treatment and an ECG with left bundle branch block (LBBB). However, it is not always ideal because of several drawbacks such as phrenic nerve capture, inability to reach late activated areas and many more. Direct HIS pacing can in many cases capture the left bundle and provide normal electrical activation of the left ventricle but sometimes with high pacing thresholds. Recently direct left bundle branch pacing has shown promise with synchronous activation of the left ventricle at low pacing thresholds.

In the present study the investigators randomize 125 patients in one center to either conventional CRT (45 patients) or HIS/LBB pacing (80 patients). In the HIS/LBB arm, direct HIS-pacing is attempted first but if its not possible or the pacing threshold for capturing the left bundle branch is > 2.5 V at 1 ms the investigators switch to placing a LBB-lead.

Power calculation for non-inferiority: With the 50 patients in the first His Alternative study (25 Biv-CRT og 25 His-CRT) the investigators observed a fall in systolic volumes of 34% and 46% with a standard deviation of 13-16%. Using these numbers it would take at least 108 patients to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (equal to a 95% two-sided confidence interval) would be over the non-inferiority limit of -10%.

Being tested
HIS/LBB pacing, LV pacing
Medical subject headings
Heart Failure, Bundle-Branch Block

What participants receive

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

  • HIS/LBB pacingDevice

    3830 lead to HIS or LBB

  • LV pacingDevice

    LV lead in a CS branch

Study groups in NCT05814263
Study groupRoleWhat they receive
HIS/LBB pacingExperimentalIn this arm a right ventricular (RV) lead or implantable cardioverter defibrillator (ICD) lead is placed first and then implantation of a HIS-pacing lead is attempted. If it is not possible to find and pace HIS, to correct the LBBB or the threshold for correcting the LBBB is > 2.5 V at 1 ms, implantation of a LBB-pacing lead is attempted instead. If that is not possible either, a left ventricular (LV) lead is implanted. Intervention: Device: HIS/LBB pacing
Receives: Device: HIS/LBB pacing
LV pacingActive comparatorIn this arm an RV-lead or ICD-lead is placed first and then implantation of a LV-pacing lead is attempted. If this is not possible due to anatomical difficulties (no coronary sinus (CS) access, no available branches other than v cordis anterior or v cordis media) or electrical difficulties (no capture below 4 V at 1.0 msec or phrenic nerve stimulation < 2x pacing threshold), implantation of a HIS-pacing lead is attempted instead. If that is not possible or the threshold for correcting the LBBB is > 2.5 V at 1 ms, implantation of a LBB-pacing lead is attempted instead. Intervention: Device: LV pacing
Receives: Device: LV pacing

What is being measured

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

  1. Change in Left ventricular end-systolic volume

    Echocardiographic response after 6 months defined as decrease in left ventricular systolic volume of ≥ 15% of baseline

    Measured: 6 months

  2. Success rate of implanting a HIS-bundle lead with capture of the left bundle branch or a LBB-lead with narrowing of QRS

    The success rate of implanting a pacing lead to the HIS-bundle with capture of the left bundle at a threshold < 2.5 V at 1 ms or implantation of a LBB lead with narrowing of the QRS duration and maintaining this effect at 6 month follow-up

    Measured: 6 months

Secondary outcomes (7)

  1. Change in LVEF and left ventricular chamber dimensions

    Echocardiographic response assessed by chamber dimensions and LVEF on a continuous scale

    Measured: 6 months

  2. Change in 6-min hall-walk test

    Functional response after 6 months defined as an increase in 6-min walking distance of ≥ 20% of the initial value

    Measured: 6 months

  3. Change in NYHA class

    Symptomatic response after 6 months defined as a fall in NYHA class of ≥ 1

    Measured: 6 months

  4. Change in Minnesota Living with Heart Failure score

    Change in well-being after 6 months defined as a decrease in Minnesota Living With Heart Failure score of ≥ 15% of baseline

    Measured: 6 months

  5. Shortening of QRS duration

    Shortening the duration of the QRS complex defined as the widest paced QRS complex rated at 12-lead ECG after 6 months

    Measured: 6 months

  6. Change in NT-pro BNP value

    Change in NT-pro BNP value

    Measured: 6 months

  7. Complications

    Device-related complications (periprocedural: electrode reoperation, pneumothorax, hemothorax, pericardial bleeding/tamponade and later (after 30 days post implantation): LV/HIS electrode reoperation, change of device due to battery depletion and infection requiring extraction).

    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 posted14 Apr 2023
  2. Study start1 Dec 2023
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2025 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05814263
Sponsor's protocol ID
22HH7978
Status last verified
Apr 2024
First submitted
16 Mar 2023
Last updated
5 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will share data with international arm of the project NCT04409119

Questions about this trial

What is this clinical trial studying?

A study testing HIS/LBB pacing and LV pacing in people with Heart Failure and Left Bundle-Branch Block, run by Imperial College Healthcare NHS Trust 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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?

Results are not available in the source record.

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

Contact Daniel Keene, MBChB (020 3313 1000, daniel.keene@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Left ventricular end-systolic volume (time frame: 6 months). 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 NCT05814263.

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 5 Apr 2024.

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HIS Alternative II - UK Site (NCT05814263) | AzTrials