Evaluating a new pacing method for heart failure patients
Acute Response to Left Bundle Branch Area Pacing With SyncAV
This study is testing a new pacing method for heart failure patients to see if it can improve their heart function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (San Donato Milanese, MI) |
| Trial ID | NCT06436053 on ClinicalTrials.gov |
What this trial studies
This clinical investigation is a prospective, single-arm, post-market study that aims to assess the effectiveness of the SyncAV dynamic atrioventricular delay feature in conjunction with left bundle branch area pacing (LBBAP) for patients with heart failure. The study will involve patients who are scheduled to receive an Abbott pacing system and have specific conduction abnormalities. By monitoring the outcomes of these patients, the study seeks to provide insights into the benefits of this pacing approach in improving heart function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with left bundle branch block or intraventricular conduction delay who require dual-chamber pacing or cardiac resynchronization therapy.
Not a fit: Patients with high resting heart rates, significant AV block, or recent cardiac events may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance heart function and quality of life for patients with heart failure.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for heart failure patients with pacing interventions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Donato Milanese, MI
- I.R.C.C.S. Policlinico San Donato — San Donato Milanese, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Nima Badie, PhD
- Email: nima.badie@abbott.com
- Phone: 408-702-8604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.