Trials
Search / Trial NCT06436053

Acute Response to Left Bundle Branch Area Pacing With SyncAV

Launched by ABBOTT MEDICAL DEVICES · May 29, 2024

Trial Information

Current as of February 18, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new method called SyncAV, which is designed to improve heart function in patients with heart failure who need a special type of pacemaker called dual-chamber pacing or cardiac resynchronization therapy. The focus of the study is on how well the SyncAV feature works when used with a specific pacing technique known as left bundle branch area pacing (LBBAP). By participating in this trial, patients will help researchers understand how this new technology can benefit those who have a condition called left bundle branch block (LBBB), which affects how the heart beats.

To be eligible for the study, participants must be at least 18 years old and have certain heart conditions, including LBBB or intraventricular conduction delay. They should also have a specific heart rhythm that allows for pacing. However, some individuals may not qualify if they have a very fast heart rate, certain types of heart block, or other medical conditions that could interfere with the study. Those who join the trial can expect regular check-ups to monitor their heart health and the effectiveness of the SyncAV feature. This trial is currently recruiting participants, and it's a great opportunity for those who meet the criteria to contribute to important research that could improve treatment options for heart failure.

Gender

ALL

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

About Abbott Medical Devices

Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.

Locations

San Donato Milanese, Mi, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0