Acute Response to Left Bundle Branch Area Pacing With SyncAV

NCT06436053 | Recruiting

• 1 other identifier: ABT-CIP-10516
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Outcome Measures

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.

  During the intervention/procedure/surgery

Secondary Outcomes (1)

• LV hemodynamics

  During the intervention/procedure/surgery

Study Arms (1)

LBBAP with SyncAV

Device: LBBAP with SyncAV

Interventions

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.

LBBAP with SyncAV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

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

San Donato Milanese, MI, 20097, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Nima Badie, PhD

CONTACT

408-702-8604; nima.badie@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)