Recruiting NCT06436053
Acute Response to Left Bundle Branch Area Pacing With SyncAV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LBBAP with SyncAV.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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.
Primary outcome measures
- QRS duration [Time frame: During the intervention/procedure/surgery]
Secondary outcome measures (1)
- LV hemodynamics [Time frame: During the intervention/procedure/surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- I.R.C.C.S. Policlinico San Donato — San Donato Milanese
Identifiers
NCT: NCT06436053 · ABT-CIP-10516