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Heart device tweak aims to help Non-Responders

NCT ID NCT04763460

Knowledge-focused Sponsor: Minneapolis Heart Institute Foundation 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This study planned to test a new way to program cardiac resynchronization therapy (CRT) devices for heart failure patients who didn't get enough benefit from standard settings. Researchers would use ECG and cardiac MRI to find the best device settings and measure changes in heart function. However, the study was withdrawn before any participants were enrolled.

What this could mean

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

Active substance
CRT device programming optimization
What this could lead to
If successful, this could lead to better ways to program CRT devices for heart failure patients who don't respond to standard settings.
What could go wrong
The study was withdrawn before enrolling any participants, so no results are available. It's unclear if the approach would work in practice.

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.

Expected to start

Jun 2023

An estimate. Start dates often move.

Finished

Mar 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 to 100 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: 1. Currently on standard medical therapy 2. CRT device in place for \> 4 months 3. Non-responder (ejection fraction improvement with CRT \< 5%) or incomplete responder (ejection fraction \< 40%) 4. Suboptimal electrical wavefront fusion at current CRT programming as observed on 12-lead ECG 5. Left bundle branch block, interventricular conduction delay or right ventricular paced underlying QRS complex 6. Age \> 18 years Exclusion Criteria: 1. Decompensated heart failure 2. Right bundle branch block 3. Pregnancy or lactation 4. History of severe allergic reactions to ECG gels, electrode adhesives, and/or cardiac magnetic resonance contrast (e.g. gadolinium) 5. Implantation of pacing lead in the his bundle or left bundle branch 6. Frequent ventricular ectopy as defined as \>10% premature ventricular contraction burden by either device interrogation or Holter monitor, or sustained ventricular tachycardia/ventricular fibrillation 7. Uncontrolled atrial fibrillation (HR \> 100 bpm) 8. Patient is enrolled in concurrent research study that would potentially confound the results of this study (noting: co-enrollment acceptable if patient is enrolled in registry study)

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure, systolic

Contacts and locations

Locations

  • Minneapolis Heart Institute - Abbott Northwestern Hospital (MHI West)

    Minneapolis, Minnesota, 55407, United States

  • United Heart & Vascular Clinic - Nasseff Specialty Center (MHI East)

    Saint Paul, Minnesota, 55102, United States

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