Acute Response to Left Bundle Branch Area Pacing With SyncAV

Heart Failure Clinical Trial

Official title:

Acute Response to Left Bundle Branch Area Pacing With SyncAV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436053
• Other study ID #: ABT-CIP-10516
• Status: Recruiting
• Start date: May 15, 2024
• Est. completion date: July 15, 2026

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: Nima Badie, PhD
• Phone: 408-702-8604
• Email: nima.badie[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 15, 2026
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• LBBAP with SyncAV
Acute changes in surface ECG QRS duration resulting from left bundle branch area pacing using various pacing configurations will be evaluated.

Locations

Country	Name	City	State
Italy	I.R.C.C.S. Policlinico San Donato	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	During the intervention/procedure/surgery