New pacemaker study aims to help heart failure patients with mildly reduced pumping function
NCT ID NCT05652218
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a special pacemaker (cardiac resynchronization therapy, or CRT) can improve heart function and symptoms in people with mild heart failure and a specific type of heart block called left bundle-branch block. About 21 participants will receive a CRT device and be randomly assigned to have it set to either a standard pacing mode or a newer left bundle-branch pacing mode. The main goal is to see if the device can improve a measure of heart pumping efficiency over time.
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 pacemaker
- What this could lead to
- If successful, this could offer a new pacing option to improve heart function and reduce symptoms in patients with mild heart failure who currently have limited treatment choices.
- What could go wrong
- This is a very small early-phase trial with only 21 participants, so results may not apply to everyone. The device implant carries standard risks like infection or lead problems, and the benefit over existing treatments is unproven.
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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21 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female aged ≥18 years * Strict LBBB defined as QRS duration ≥130ms in women and ≥140ms in men, a QS or rS complex in V1 and V2, as well as notching or QRS slurring in mid-QRS in ≥2 contiguous leads. * NYHA II/III, ambulatory NYHA IV, or NYHA I HF with any prior history of HF symptom decompensation requiring hospitalization, ED visit, or outpatient visit for care with IV diuretic * LVEF \>35% by clinically obtained echocardiogram overread by the study core-lab * Demonstration of adequate echocardiographic images to allow for assessment of endpoints * On a stable guideline directed HF medical regimen * For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation * Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. Exclusion Criteria: * Patients with anticipated addition or titration of HF medical therapies (ACE/ARB/ARNI, beta blocker, MRA, SGLT2 inhibitor) during the duration of the study * Treatment with another investigational drug or other intervention within 3 months * Current unrevascularized coronary artery disease, unstable angina, acute MI, CABG, or PCI within the past 3 months * Significant non-functional mitral or aortic valvular disease (severe stenosis or regurgitation) * Significant structural heart \[including hypertrophic cardiomyopathy (septal thickness ≥15 mm) or infiltrative cardiomyopathy (eg. amyloid)\] * Current moderate to severe pulmonary hypertension (right ventricular systolic pressure of ≥40 mmHg) * Oxygen dependent chronic lung disease * Prolonged episodes of AF (\>3 days or an AF burden \>10%) within the preceding 3 months * Presence of cardiac pacemaker or implantable cardioverter defibrillator * Prior mechanical tricuspid valve replacement * Pregnancy or lactation due to concerns about the effect of radiation from the pacemaker implantation procedure on the fetus * Known allergic reactions to components of the pacemaker or leads * Febrile illness within 3 days of trial enrollment * Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. * Control Participant Exclusion Criteria: same
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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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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Inova Health System
Falls Church, Virginia, 22042, United States
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Other studies related to the condition(s) this trial covers.
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