Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

This study is looking for adults aged 18 or over who have had a new ALIZEA, BOREA, or CELEA pacemaker fitted within the last 20 days. You would also need to have specific types of wires (called leads) connected to your heart and be happy for the remote monitoring features of your pacemaker to be switched on and used.

There are also some reasons why you wouldn't be able to join. For example, if you already have a different type of heart device like a defibrillator, or if you have certain existing heart conditions like a permanent irregular heartbeat called atrial fibrillation. You also can't take part if you're involved in another medical study that might affect the results of this one, or if you have certain medical conditions that might make a pacemaker unsuitable.

It's important that you would be able to attend all the follow-up appointments over the next four years. Unfortunately, women who are still able to have children (pre-menopausal) are not able to join this particular study.

If you join this study, you'll be included shortly after your pacemaker is put in. You'll then be followed for four years. During this time, you'll have regular check-ups, both in person at the clinic and possibly remotely (from home). These check-ups will happen around 1-3 months, 6 months, 1 year, 2 years, and 4 years after you join.

At each visit, the team will check how well your pacemaker's remote monitoring features are working and how your pacemaker system in general is performing. They will also keep an eye on your safety throughout the entire four years of the study. You won't be given any new medication as part of this study; it's focused on checking the pacemaker device itself. The total duration of your involvement would be 48 months, or four years.