RecruitingNAINTERVENTIONAL

Diagnosis of Postoperative Atrial Fibrillation by a Smartwatch

Heart surgery can sometimes lead to an irregular heartbeat called atrial fibrillation (AF), which can be serious but often has no symptoms. This irregular heartbeat, or POAF, usually happens a few days after surgery, often when patients are out of critical care and not being constantly monitored. This study wants to see if smartwatches, which can record a simple heart tracing (ECG) and analyse heart rhythms, can effectively detect these AF episodes early on. Catching AF early can help prevent other serious problems like stroke. The goal is to diagnose POAF within the first five days after a patient leaves critical care and moves to the general heart surgery ward.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

324

Start

06 Oct 2022

Estimated completion

06 Jul 2028

Atrial Fibrillation Cardiac Surgery

What is this study about?

When people have heart surgery, especially a type called 'on-pump' surgery which uses a heart-lung machine, there's a chance they might develop an irregular heartbeat shortly afterwards. This is called postoperative atrial fibrillation, or POAF. It can affect about 3 in every 10 patients. POAF can be serious, increasing the risk of complications like stroke, other heart problems, and even death. It can also mean a longer stay in hospital and higher treatment costs.

Often, people with POAF don't feel any symptoms, which makes it tricky to spot. These irregular heartbeats usually start about three to four days after surgery. At this point, patients have often moved out of the highly monitored intensive care unit and onto a regular ward, where continuous heart rhythm monitoring might not be standard. Doctors usually only check for POAF with a full heart tracing (ECG) if a patient shows symptoms or if their heart rate changes significantly. But identifying these silent episodes is really important because they still come with risks.

This is where technology like smartwatches comes in. Many smartwatches can record a simple heart tracing, similar to an ECG, and have built-in tools to detect irregular heart rhythms. Major heart organisations already suggest using smartwatches to help find AF. This study wants to find out if these smartwatches can be a good way to diagnose POAF within the first five days after patients leave critical care and are recovering on the cardiac surgery ward, helping to catch these issues early and improve patient care.

Key takeaways

This study explores using smartwatches to detect irregular heartbeats (POAF) after heart surgery.
POAF is common (about 3 in 10 patients) and often has no symptoms but can be serious.
Early detection of POAF could help prevent complications like stroke.
The study focuses on patients in the first five days after leaving critical care.
Smartwatches offer a convenient way to monitor heart rhythm.
Major heart organisations support using smartwatches for AF detection.

Who may be eligible?

To be considered for this study, you need to be an adult over 18 years old. You must have recently had a specific type of heart surgery (called 'on-pump' cardiac surgery) at the Amiens University Hospital within the last 96 hours. You also need to be well enough, both physically and mentally, to use a smartwatch to record your heart rhythm.

You must have been transferred to the heart surgery ward at Amiens University Hospital and be covered by a social security plan in France. Lastly, you’ll need to sign a consent form to show you understand and agree to take part in the study.

There are also some reasons why you wouldn't be able to join. For example, if you already have a history of atrial fibrillation, or if you need continuous heart monitoring for other serious heart rhythm problems. If you have an external pacemaker, are already in another clinical study that might affect POAF, or if you are pregnant, you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Did you have on-pump heart surgery at Amiens University Hospital recently (within the last 4 days)?
Are you able to use a smartwatch to take a heart reading?
Do you not have a history of an irregular heartbeat (AF)?
Are you currently not pregnant?
Are you not in another clinical study that might affect your heart rhythm?

Answer every question to see your result.

What does participation involve?

The study does not specify particular visits, tests, or medication beyond the use of a smartwatch. It is focused on diagnosing POAF within the first five days after you've left the critical care unit and are on the cardiac surgery ward. This suggests that your participation would primarily involve using a smartwatch as instructed during this post-surgery period while in hospital. The total duration of your active involvement would likely be limited to these first five days after moving to the ward.

Potential risks and benefits

Taking part in this study could potentially lead to earlier detection of an irregular heartbeat (POAF), which might help doctors manage your care more effectively and potentially prevent future complications. The risks of using a smartwatch are generally very low, as these are common consumer devices. However, it's important to remember that relying solely on a smartwatch for diagnosis without medical confirmation is not recommended. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

CHU Amiens Picardie
Verified postcode
Amiens, France· Recruiting

Common questions

What is POAF?

POAF stands for Postoperative Atrial Fibrillation. It's an irregular heartbeat that can happen after heart surgery.

Why is it important to detect POAF early?

Catching POAF early can help prevent serious problems like stroke or other heart issues, and potentially shorten your hospital stay.

How would the smartwatch help?

The smartwatch can record a simple heart tracing (ECG) and check your heart rhythm, possibly finding irregular beats even if you don't feel them.

Do I need special training to use the smartwatch?

The study requires you to have the ability to use the smartwatch to perform a simple heart tracing. Instructions would be provided.

What if I decide I don't want to be in the study anymore?

You can leave the study at any time without it affecting your medical care, and you don't need to give a reason.

How to find out more

Christophe Beyls, MD

beyls.christophe@chu-amiens.fr 03 22 08 78 66 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.