This study is testing a new device called the Calyan Pacemaker. It's designed to help people with bradycardia (a slow heart rate) who need a single-chamber ventricular pacemaker. The pacemaker is implanted in your chest and helps your heart beat at a regular pace. Researchers want to see how safe the Calyan Pacemaker is and if it works well over 3 months. They will look for any serious problems related to the procedure or device, and check if it successfully paces the heart. You might be able to join if you are 18 or older, need a single-chamber ventricular pacemaker, and are expected to live at least one more year. The study is currently unclear about its recruitment status.

Study design

This is an early study with a planned enrollment of 10 participants. It is an interventional study, meaning participants will receive the Calyan Pacemaker.

What's involved

The Calyan Pacemaker will be implanted, and if it works well initially, you will receive chronic pacing for a 3-month period. There will also be extended follow-up after this initial period.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for at least 3 months, with subsequent extended follow-up for all patients.

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