Acute Response to Left Bundle Branch Area Pacing With SyncAV

Abbott Medical Devices1 site in 1 country50 target enrollmentMay 15, 2024

ConditionsHeart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 50
Locations: 1
Primary Endpoint: QRS duration
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

May 15, 2024

End Date

July 15, 2026

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.