Acute Response to Left Bundle Branch Area Pacing With SyncAV
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
LBBAP with SyncAV
DeviceAcute changes in surface ECG QRS duration resulting from left bundle branch area pacing using various pacing configurations will be evaluated.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: LBBAP with SyncAV1 intervention
Trial outcomes
Primary outcomes
1
QRS duration
Acute change in surface ECG QRS duration resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.
Time frame
During the intervention/procedure/surgerySecondary outcomes
1
LV hemodynamics
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.
Time frame
During the intervention/procedure/surgerySponsors and contacts
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Source ClinicalTrials.gov