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Precision lead placement could boost heart failure device success

NCT ID NCT03280862

Disease control Sponsor: Aarhus University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether placing the left ventricle lead of a cardiac resynchronization therapy (CRT) device at the heart's latest electrical activation spot improves outcomes. It included 1,000 heart failure patients with bundle branch block. The goal was to see if this targeted approach reduces death or unplanned heart failure hospitalizations compared to standard lead placement.

What this could mean

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

Active substance
Cardiac resynchronization therapy (CRT) device implantation
What this could lead to
If successful, this approach could reduce deaths and hospitalizations for heart failure patients by improving how the device is placed.
What could go wrong
The trial is completed but results are not yet widely confirmed. Targeted placement may increase procedure time, infection risk, or radiation exposure, and might not benefit all patients.

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

1,000 people

The number who actually took part.

Started

Mar 2018

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

40 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: * Heart Failure, NYHA II, III, outpatient IV * LVEF ≤35% measured by echocardiography * Optimal medical treatment for heart failure * Bundle Branch Block * Indication for primary CRT-D or CRT-P implantation or upgrade from RV pacing (pacemaker or ICD) to CRT-D or CRT-P * Ischemic heart disease (IHD) or non-IHD * Sinus rhythm or atrial fibrillation * Life expectancy \>2 years * Signed informed consent Exclusion Criteria: * NYHA class I * Acute mycardial infarction (AMI) within the latest 3 months * Coronary artery bypass graft (CABG) within the latest 3 months * Life expectancy \<2 years * Participation in another clinical trial of experimental treatment * Contraindication for establishing implantable device treatment * Previously implanted CRT system * Does not wish to participate

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Conditions

The condition(s) this trial relates to.

bundle branch block, familial isolated complete right 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.

Branch block, bundle Heart failure

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    Aarhus, 8200, Denmark

  • Gentofte University Hospital

    Gentofte Municipality, 2900, Denmark

  • Odense University Hospital

    Odense, 5000, Denmark

  • Rigshospitalet

    Copenhagen, 2100, Denmark

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