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Recruiting Observational

Acute Response to Left Bundle Branch Area Pacing With SyncAV

NCT06436053 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-05-15
Last updated
2026-07-09

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

LBBAP with SyncAV

LBBAP with SyncAV: Acute changes in surface ECG QRS duration resulting from left bundle branch area pacing using various pacing configurations will be evaluated.

Study summary

This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left bundle branch area pacing (LBBAP).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • QRS duration — During the intervention/procedure/surgery
    Acute change in surface ECG QRS duration resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.

Trial sites (1)

FacilityCityRegionStatus
I.R.C.C.S. Policlinico San Donato San Donato Milanese MI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06436053 on ClinicalTrials.gov ↗ ← All trials in Italy