This study is testing the LivIQ Leadless Pacemaker System, a small device implanted directly into the heart, for people with slow heart rates (bradycardia) or heart block (AV Block). The goal is to see if the device is safe and works well for patients who need a pacemaker. Researchers will be looking at how many people experience serious problems with the device and how well the pacemaker helps the heart beat correctly. You might be able to join if you are at least 18 years old and your doctor has recommended a ventricular pacemaker. The study aims to enroll 325 participants.

Study design

This is an open-label, single-arm study, meaning all participants will receive the LivIQ Leadless Pacemaker System and everyone will know what treatment they are getting. Up to 325 people will participate across multiple centers.

What's involved

You will have several in-person visits, including at enrollment, implant, before leaving the hospital, and at 1, 3, 6, and 12 months. After that, you'll have visits every 6 months until the device is approved for wider use.

Compensation

Not stated in the trial record.

Follow-up

You will be followed for at least 12 months with in-person visits, and then every 6 months until the device receives market approval. A remote 24-month visit will assess vital status after U.S. market approval.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.