NCT06436053 Acute Response to Left Bundle Branch Area Pacing With SyncAV
| NCT ID | NCT06436053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-05-15 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06436053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06436053 currently recruiting?
Yes, NCT06436053 is actively recruiting participants. Contact the research team at nima.badie@abbott.com for enrollment information.
Where is the NCT06436053 trial being conducted?
This trial is being conducted at San Donato Milanese, Italy.
Who is sponsoring the NCT06436053 clinical trial?
NCT06436053 is sponsored by Abbott Medical Devices. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.