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Could direct heart pacing beat standard therapy for heart failure?

NCT ID NCT07492979

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This study compares a newer pacing method (HIS or left bundle branch pacing) to the standard biventricular pacing in 1100 heart failure patients across Nordic countries. The goal is to see if the new approach reduces death or unplanned heart failure hospitalizations. Participants must have severe heart failure and a specific heart block pattern.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Conduction system pacing (HIS bundle or left bundle branch pacing) procedure
What this could lead to
If successful, this could offer a more effective pacing method for heart failure patients, potentially reducing deaths and hospital stays.
What could go wrong
This is a large trial but has not yet started recruiting. The new pacing technique may not prove superior and carries procedural risks like bleeding or lead complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ≥18 years of age, * LVEF ≤ 35%, * NYHA Class II-IV (IV only outpatients), * optimized in medical treatment (OMT) AND one of the following: . LBBB according to AHA/ACC/HRS Scientific Statement from 2009 and ≥130ms or * LBBB-like intraventricular conduction delay (IVCD) \> 150ms or RV paced QRS and indication for upgrade to CRT (\> 40% RV pacing) OR * ≥18 years of age, * LVEF ≤ 40 % * pacing indicated by AV-block and, thus, expected large percentage of ventricular pacing. Exclusion Criteria: * recent acute myocardial infarction (AMI) * coronary artery bypass graft (CABG) (\<3 months) * life expectancy \<2 years, patients in hemodialysis * treatment with a cardiac implantable electronic device (CIED) is contraindicated. * Patients are excluded with regards to the MRI sub study if eGFR \> 35 ml/min, in case or contrast allergy or certain metal implants.

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Conditions

The condition(s) this trial relates to.

conduction system disorder heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac resynchronisation therapy (CRT) Conduction system pacing Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dept of Cardiology, Meilahti Hospital, Helsinki

    NOT_YET_RECRUITING

    Helsinki, 00290, Finland

  • Dept. of Cardiology, Aarhus University Hospital, Aarhus

    NOT_YET_RECRUITING

    Aarhus, 8200, Denmark

  • Haukeland Universitetssykehus

    NOT_YET_RECRUITING

    Bergen, 5009, Norway

  • Rigshospitalet, Copenhagen University Hospital

    RECRUITING

    Copenhagen, 2100, Denmark

  • Sahlgrenska University Hospital

    NOT_YET_RECRUITING

    Gothenburg, Sweden

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