Evaluating a new pacing method for heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.