NCT03803995Completed
Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block
Source: ClinicalTrials.gov · Last updated 2 Oct 2025
Brief summary (registry, in English)
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 4 Jan 2019
- Start date
- 20 Mar 2019
- Primary completion date
- 20 Apr 2024
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Heart failure
- NCT number
- NCT03803995
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 20 Mar 2019 to the primary completion date, 20 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously implanted cardiac devices with three or more permanent leads
Other illness
- History of aortic valve repair or replacement
- History of tricuspid valve replacement
- 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
- 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.
Other
- Patients have non-specific intraventricular conduction delay or right bundle branch block
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
Who the study is looking for
- Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
- An ECG with a wide QRS complex (\>130 ms)
- ECG morphology of typical complete LBBB,
- Patients have heart failure with NYHA Class II-IV symptoms,
- LV EF \<50%
- At least 18 years old and not pregnant.
- Must provide written informed consent prior to any clinical investigation related procedure.
- Willing to comply with study evaluation requirements
- 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.)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.