Pacemaker tweak may boost heart function in failure patients
NCT ID NCT06436053
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests a special pacemaker setting called SyncAV, used with left bundle branch area pacing, in people with heart failure and a heart block. The goal is to see if this setting can improve the heart's electrical timing and pumping strength. About 50 adults who already need a pacemaker will take part, and researchers will measure changes in heart function during the procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Left bundle branch area pacing with SyncAV feature
- What this could lead to
- If successful, this could improve heart pumping efficiency and reduce symptoms for people with heart failure who need a pacemaker.
- What could go wrong
- This is a small, early-stage study looking at short-term effects only. Long-term benefits or risks are not yet known.
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.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- 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.
Who is studied
Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy, with documented left bundle branch block or intraventricular conduction delay, long QRS duration, and intact AV conduction will be enrolled.
- 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. Patient is 18 years of age and willing to comply with the study requirements 2. Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an Abbott pacing system 3. Patient has documented left bundle branch block (LBBB) or intraventricular conduction delay (IVCD) 4. Patient has an intrinsic QRS duration ≥ 130 ms 5. Patient has intact AV conduction with PR interval ≤ 250 ms Exclusion Criteria: 1. Patient has a resting ventricular rate \> 100 bpm 2. Patient has AV Block (2nd or 3rd degree) 3. Patient has documented persistent atrial tachycardia or atrial fibrillation 4. Patient has had a recent myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacing device programming changes in the opinion of the investigator 5. Patient is currently participating in another clinical investigation 6. Patient is pregnant or nursing 7. Patient has other medical, anatomic, comorbid, 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 8. Patient does not have legal authority 9. Patient is unable to read or write
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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I.R.C.C.S. Policlinico San Donato
RECRUITINGSan Donato Milanese, MI, 20097, Italy
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