Acute Response to Left Bundle Branch Area Pacing With SyncAV
Recruiting
Observational Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Abbott Medical Devices · Industry
Who this trial is looking for
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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).
Trial Locations
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Status
Eligibility Criteria
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 bran…
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
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