New mapping technique may improve pacing for heart failure patients
NCT ID NCT03803995
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
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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
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18 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Apr 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Tampa General Hospital
Tampa, Florida, 33606, United States
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