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New mapping technique may improve pacing for heart failure patients

NCT ID NCT03803995

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 18 heart failure patients with a specific heart block to find the best spots for pacing the heart's natural electrical system. Doctors used a 3D mapping system during device implant to see where pacing corrects the heart's rhythm. The goal was to gather information, not to test a new treatment.

What this could mean

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

What this could lead to
If successful, this could help doctors better target pacing leads during heart device implants to improve heart function.
What could go wrong
This is a small, early-stage mapping study with only 18 people, so results may not apply to all patients. It does not test long-term outcomes.

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

18 people

The number who actually took part.

Started

Mar 2019

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications 2. An ECG with a wide QRS complex (\>130 ms) 3. ECG morphology of typical complete LBBB, 4. Patients have heart failure with NYHA Class II-IV symptoms, 5. LV EF \<50% 6. At least 18 years old and not pregnant. 7. Must provide written informed consent prior to any clinical investigation related procedure. 8. Willing to comply with study evaluation requirements 9. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) Exclusion Criteria: 1. Patients have non-specific intraventricular conduction delay or right bundle branch block 2. Previously implanted cardiac devices with three or more permanent leads 3. History of aortic valve repair or replacement 4. History of tricuspid valve replacement 5. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. 6. Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacemaker or CRT implant in the opinion of the investigator 7. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

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