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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06436053
Other study ID # ABT-CIP-10516
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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