Heart Failure
Conditions
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).
Interventions
DEVICELBBAP with SyncAV
Acute changes in surface ECG QRS duration resulting from left bundle branch area pacing using various pacing configurations will be evaluated.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
CONTACTNima Badie, PhD
Outcome results
None listed