RecruitingNCT06436053

Acute Response to Left Bundle Branch Area Pacing With SyncAV


Sponsor

Abbott Medical Devices

Enrollment

50 participants

Start Date

May 15, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • Patient is 18 years of age and willing to comply with the study requirements
  • Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an Abbott pacing system
  • Patient has documented left bundle branch block (LBBB) or intraventricular conduction delay (IVCD)
  • Patient has an intrinsic QRS duration ≥ 130 ms
  • Patient has intact AV conduction with PR interval ≤ 250 ms

Exclusion Criteria9

  • Patient has a resting ventricular rate \> 100 bpm
  • Patient has AV Block (2nd or 3rd degree)
  • Patient has documented persistent atrial tachycardia or atrial fibrillation
  • 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
  • Patient is currently participating in another clinical investigation
  • Patient is pregnant or nursing
  • 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
  • Patient does not have legal authority
  • Patient is unable to read or write

Interventions

DEVICELBBAP with SyncAV

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


Locations(1)

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, MI, Italy

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NCT06436053


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