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The Zio Patch is a new piece of medical equipment, made by iRhythm Technologies Inc. based in San Francisco, USA. The Zio Patch has been created to monitor your heart rhythm for 2 weeks. The patch simply sticks to the your chest, over your heart, and can be easily peeled off once you’ve finished using it. People who have worn the patches have found them discrete and comfortable to wear. They are water-resistant so can be worn in the shower or bath, although swimming should be avoided. All the heart rhythm information from the patch is analysed by iRhythm’s computer systems and a full report is sent back to your GP. The Zio Patch has already been put through thorough testing in America and the UK. It has been approved by the USA Food and Drug Administration Department and awarded a CE mark in Europe for diagnosing atrial fibrillation.

The AMALFI study has been designed to see if using  the Zio Patch, will increase the number of people detected early with atrial fibrillation and therefore to bring down their risk of having a stroke. To do this we hope to recruit around 2,500 people, half of whom will be asked to wear a patch and half of whom won’t need to. The reason for this approach is because we need to compare different treatments to find out which one is best for patients, so we divide participants into groups and give each group a different treatment. The groups are then compared to see if one treatment is better. In AMALFI, we will count how many people are diagnosed with atrial fibrillation over the next 5 years and analyse if there was any difference between those who had a patch and those who didn’t.

Unfortunately this is not possible. In clinical trials like AMALFI, we need to compare different treatments to find out which one is best for patients. To do this we divide the study participants into two groups and give each group a different treatment - the groups are then compared to see if one treatment is better. To make sure that the only difference between the groups is the treatment they receive; the computer matches the two groups for all other factors (such as age and gender) – this is a process called ‘randomization’. Therefore you can only have a patch if the computer allocates you to that group.

The patch should be worn continuously for 2 weeks. This may seem a long time but it will provide the most information possible about what your heart is doing during that time.

The patch is recording every heartbeat and storing the data so that it can be analysed by iRhythm’s computer systems. A report will then be produced, analysed and sent back to your GP with any abnormalities noted for the GP’s attention.

Yes but try to avoid intense exercise, particularly if prone to heavy sweating, as this may shorten the wear time.

Yes but showers should be avoided for the first 24 hours and then kept brief. The optimal is short duration with your back to the shower head. Please keep soaps and lotions away from the Zio Patch. When towel-drying, hold the Zio Patch down with one hand to secure it so that it is not accidently knocked off.

Yes but keep the Zio Patch above water. Please keep soaps and lotions away from the Zio Patch. When towel-drying, hold the Zio Patch down with one hand to secure it so that it is not accidently knocked off.

No. The Zio Patch should not be submerged in water.

Yes. The Zio Patch may move slightly from its original position. A blue gel may become visible under the wings of the patch.

Some itching is normal, especially during or immediately after exercise and/or excessive sweating. The itching should subside when you cool down. If severe, you should remove the Zio Patch and contact the clinical trials team.

Yes, the wings of the patch may become cloudy after a few days of wear.

Swimming and any activities that cause excessive sweating which can cause the Zio Patch to slide or become loose and so shortening the wear time.

No, if the Zio Patch is over the heart in a slight diagonal as shown the positioning should be acceptable.  DO NOT attempt to reapply the Zio Patch.

You should have seen a brief green flash after pushing the Zio button when first attaching the patch, which means it is working. After this the Zio Patch will not flash or make a noise if all is well. If you would like to check press and hold the Zio button until the brief green flash occurs (~10 seconds).

An orange flash means that the patch is not well attached. Apply continuous pressure across two sticky pads for 2 minutes to try and re-adhere it. If the Zio Patch continues to flash orange, call the clinical trials support team for further advice.

If the patch comes loose, you can add some extra tape (e.g. Micropore) or a film dressing (e.g. Tegaderm) to help stick it down. These items should be available from Boots, a local Pharmacy or large supermarket. Once in place, apply continuous pressure across the patch for 2 minutes to try and re-adhere it.

If the patch falls off completely and can’t be reattached, please return it to iRhythm in the postage-paid box for analysis.

Yes. If questioned during security screening, show the security screening statement on page 13 of the Zio Patch booklet.

Yes, the patch may flash orange once removed. It is OK to post is back whilst the light is flashing.

To return, put the Zio Patch in the back of the instruction booklet and send to iRhythm in Guilford in the original box. This has pre-paid business reply label on it, so no stamp is necessary. A sticker is also supplied at the end of the instruction booklet to seal the box.

Remember, the results will go back to your GP who may want to discuss the findings with you.

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