Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status

Launched by XIAOHAN FAN · Sep 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to understand what factors influence the choice of a specific type of heart device called a double-chamber leadless pacemaker for patients with a condition known as atrioventricular block. This condition affects how electrical signals travel through the heart, which can lead to a slow heartbeat. The study will observe patients over time to see how well this leadless pacemaker works for them. It is important to note that this trial is not yet recruiting participants.

To be eligible for this study, patients must be at least 18 years old and diagnosed with atrioventricular conduction block, meaning they can benefit from a leadless pacemaker. They also need to expect to live for at least another year and be able to provide consent for participating in the study. However, certain patients, such as those with specific heart conditions or who are pregnant, may not qualify. Participants can expect to receive a thorough evaluation and follow-ups during the study to monitor their health and the performance of the pacemaker.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".
• • 2. Age ≥18 years.
• • 3. Expected lifespan ≥1 year.
• • 4. Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups
• Exclusion Criteria:
• • 1. Patients anticipated to have a high ventricular pacing proportion (\>40%) and with left ventricular ejection fraction less than 50%.
• • 2. Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
• • 3. Post-tricuspid valve mechanical valve replacement surgery.
• • 4. Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
• • 5. Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.