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New heart pacing technique could offer alternative for heart failure patients

NCT ID NCT04409119

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared a newer pacing method, called HIS or left bundle branch (LBB) pacing, to the standard biventricular pacing in 150 heart failure patients with a specific heart electrical problem (left bundle branch block). The goal was to see if the new method could improve heart function and symptoms as well as or better than the standard approach. Researchers measured changes in heart size and pumping ability after 6 months.

What this could mean

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

Active substance
HIS/LBB pacing (a device-based pacing procedure)
What this could lead to
If successful, this could offer a more natural pacing method for heart failure patients, potentially improving heart function and symptoms.
What could go wrong
This is a completed study with 150 participants, but it is not a large-scale trial. The new pacing method may not work for everyone and could have implantation challenges or risks like lead dislodgement.

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

150 people

The number who actually took part.

Started

Jun 2020

Finished

Feb 2026

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 years and older

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: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

heart failure progressive familial heart block, type 1A

As listed by the trial registrant

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

Heart failure Left bundle branch block

Contacts and locations

Locations

  • Rigshospitalet

    Copenhagen, Capital Region, 2100, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.