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OpenTrials
Recruiting

NCT Number: NCT06436053

Acute Response to Left Bundle Branch Area Pacing With SyncAV

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

San Donato Milanese, MI, 20097, Italy

Location status: Recruiting

Location contact

Carlo Pappone, MD, PhD

CONTACT

[email protected]

+39 -0252774260

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

LBBAP with SyncAV

Device

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

Primary outcomes

  1. QRS duration

    Time frame: 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.

Secondary outcomes

  1. LV hemodynamics

    Time frame: During the intervention/procedure/surgery

    Acute change in left ventricular hemodynamics (i.e., maximum rise in pressure) resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.

Study contacts

Contact information is provided by the study sponsor or research team.

Nima Badie, PhD

CONTACT

[email protected]

408-702-8604

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 30, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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