Protection of Cardiac Function With Left Bundle Branch Pacing in Patients With Atrioventricular Block

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Nov 5, 2020

Keywords

ClinConnect Summary

The OptimPacing study is a clinical trial that is exploring a new way to help patients with a heart condition called atrioventricular (AV) block, which can affect how well the heart beats. This trial will compare two different methods of pacing the heart: Left Bundle Branch Pacing (LBBP) and conventional Right Ventricular Pacing (RVP). Researchers want to find out if LBBP is better at preserving heart function over time and if it is safe for patients. The study will take place in 11 medical centers across China and aims to enroll 683 patients over the next two years. Participants will be followed for at least three years to see how they respond to the different pacing methods.

To be eligible for the study, participants should be over 18 years old and have a need for a permanent pacemaker due to specific heart conditions, such as second-degree or complete AV block, and a heart function measurement that is above a certain level. Patients who are pregnant, have certain recent heart surgeries, or other specific conditions may not be able to participate. Those who join the trial can expect regular check-ups and monitoring to assess their heart health and how well the pacing method is working for them. This study is important as it could lead to improved treatments for patients with AV block, helping them maintain better heart function in the long run.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Indication of permanent pacemaker implantation: (1) Second degree or complete AV block; (2) Persistent or permanent atrial fibrillation with mean ventricular rate \< 50 bpm and related symptoms
• • 2. LVEF \> 35%, NYHA classification I-III
• • 3. Age \> 18 years
• • 4. Signed informed consent
• Exclusion Criteria:
• • 1. Implanted prosthetic tricuspid valve
• • 2. Unstable angina, acute myocardial infarction, CABG or PCI within the last 3 months
• • 3. Cardiac surgery like valvular replacement, TAVI, ventricular septal myectomy or ablation within the last 3 months
• • 4. Enrolled in any other study
• • 5. A life expectancy of less than 12 months or unable to undergo the planned 6. follow-up for any reasons
• • 6. Pregnant or with a child-bearing plan
• • 7. A history of heart transplantation
• • 8. Complex congenital heart disease (whether surgical correction or not) and post-surgery repair or post-closure of ventricular septal defect
• • 9. Ventricular septal hypertrophy (≥ 15mm during diastole)
• • 10. Isolated persistent left superior vena cava
• • 11. With ICD, CRT or CRTD indications
• • 12. Pacemaker replacement, upgrade and pocket infection needing re-implantation