Let's talk about the SyncAV study......

Hello Gemita

I want to follow up with you about the Abbott SyncAV study that I am participating in.

The study is completely voluntary.  And as I mentioned earlier, it is a blind study and you can also choose to have your data “de-identified”.

The study is being conducted in approximately 150 sites worldwide and includes up to 1400 subjects.

The purpose of the study is to evaluate changes in heart size between the first baseline visit and 12 months in patients with a CRT device programmed with SyncAV compared to patients with standard CRT device settings.

The study lasts approximately 14 months.  You commit to a total of 4 visits to the clinic after implant.  Each visit will take between 20 to 60 minutes depending on if your device is programmed with SyncAV or with standard settings.

In addition to collecting data, via the programmer during your clinic visits, the data from the device is also collected through remote monitoring (Merlin.net).  Combined, this data will add to the knowledge base already collected about the devices and will help improve future devices.

Your selection to be part of the study, whether as part of the SyncAV group or a part of the standard CRT programming group, is completely randomized.  A computer program, after data is entered, decides your assignment.

There are certain criteria required to be included in the study.  I seem to be lucky (?) enough to have met them including having heart failure, having been on optimal medical therapy (beta-blockers, etc.) for at least 3 months prior to signing consent, have a LVEF rate of 35% or less ( I was at 19%), and have a LBBB that met certain QRS durations and patterns (I ticked all those boxes).  Oh yeah, and be of legal age.  Check. 😊

The primary goal of the study is reduction in the left ventricular end systolic volume from baseline measurements to 12 months flowing trial randomization.

Secondary goals are to measure the number the percentage of responders at 12 months between subjects in the SyncAV and the standard programming group.

Also, to measure the reduction in heart size in female subjects between the two groups.

During any of these appointments, I have no idea which group I am in since this is a strictly a data driven study.  I do not discuss the study with either the technician or the doctor. (We do, however, discuss our favourite Caribbean vacation spots😉.)

And since the participants are so few and far flung, to actually speak to one would be as likely as finding a particular grain of sand on the proverbial beach of life.  Also, in the 11 page Participant Informed Consent Form, there is no reference to secrecy or warning to not contact or speak to anyone else, either in or out of the study.  (So, no worries there Agent X86 😉.)

I see my participation in this study as a chance to pay it forward as others have undoubtedly done for me.  I do not receive any renumeration for participating and indeed, incur some expense in the form of travel costs and time spent travelling.

I have given you the abridged version of the study info.  You can, if interested, read more about the study at ClinicalTrials.gov and enter into the search “SyncAV trials”.


2 Comments

Thank you!

by Lavender - 2023-03-07 13:23:11

Very interesting and thank you for your service! I'm grateful for anyone who helps others learn. I've always allowed students to observe when asked in dr office/hospital settings. Without this research, we wouldn't be where we are today! 

Yes thank you Beni

by Gemita - 2023-03-07 14:39:06

Yes let’s talk about the Abbott SyncAV study that you are participating in.  

Thank you so much Beni for your most comprehensive reply.  You have certainly answered all my questions and much more.  If I may say, I hope you are in the group where the SyncAV Setting is activated since it sounds an extremely promising treatment to optimise your device therapy for your heart failure.  

I think most of us know that there are still too many non responders to CRT and we need to continue to try to find better ways of addressing this.  I have read that sub optimal AV timing is a potential cause for non response to CRT.  Most devices are often left at nominal settings which are not ideal because each patient is so very different, so how we optimise their Settings to suit them individually is so important.  The Study aims to look specifically at this process and AV timing. 

Like Lavender I wish to thank you for all your efforts Beni in taking part in this study for the benefit of others at a time when perhaps you don’t always feel like pushing yourself or committing yourself to making visits to the clinic with a less than healthy ejection fraction.  

I can appreciate with only 1400 subjects involved in approximately 150 sites worldwide, the likelihood of meeting someone in this Study in person is pretty slim, although I would have thought someone here might have been enrolled in the Study, so it was certainly worth your while enquiring.

Even though you are giving your time, your energy to the Study, I hope you will receive back a great deal that will help you to enjoy a better quality of life and dare I say it, perhaps a noticeable improvement in your heart failure.  With improvements in your heart failure, you will hopefully notice benefits to your overall health and with your arrhythmias too which I feel have contributed to your heart failure/cardiomyopathy.

I send my best wishes for a very successful outcome

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The experience of having a couple of lengths of wire fed into your heart muscle and an electronic 'box' tucked under the skin is not an insignificant event, but you will survive.