Acute Response to Left Bundle Branch Area Pacing With SyncAV

Recruiting

• Conditions: Heart Failure
• Interventions: Device: LBBAP with SyncAV

• Registration Number: NCT06436053
• Lead Sponsor: Abbott Medical Devices

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-05-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-05-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LBBAP with SyncAV	LBBAP with SyncAV	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
LV hemodynamics	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.

Trial Locations

Locations (1)

I.R.C.C.S. Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy