Active not recruitingNAINTERVENTIONAL

SyncAV Post-Market Trial

This study is for people with heart failure who are getting a new, special heart device called a CRT. This device helps your heart's chambers beat together better. We want to see if a new, smart setting on these devices, called SyncAV ON, improves your heart's health more in the long run compared to the standard settings. Researchers will randomly place people into two groups: one with SyncAV ON and one with standard settings. We'll track their heart function over a year to understand which approach is more effective at helping the heart recover and pump blood better.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

1,686

Start

03 Oct 2019

Estimated completion

30 Jun 2026

Congestive Heart Failure

What is this study about?

This study is designed for individuals who have heart failure. In heart failure, your heart doesn't pump blood as well as it should, which can make you feel tired and short of breath. A special type of pacemaker, called a Cardiac Resynchronization Therapy (CRT) device, helps the different chambers of your heart beat in a more organised way, making it pump blood more efficiently. This study aims to find out if a new, smart feature on some CRT devices, called SyncAV ON, can make an even bigger difference in improving your heart's health over time.

Researchers will choose people by chance to be in one of two groups. One group will have their new CRT device programmed with the SyncAV ON feature activated. This feature is designed to fine-tune how the device works to make your heart's beats even more coordinated. The other group will have their device set up with the usual, standard settings. By comparing these two groups, doctors hope to learn if the SyncAV ON feature leads to a better and more lasting improvement in how your heart functions.

We are particularly interested in how well your heart muscle recovers and reshapes itself over time, which doctors call 'reverse remodelling'. This means the heart gets closer to its normal size and shape, which is a good sign for long-term health. The results of this study could help doctors decide the best way to program CRT devices in the future to give people with heart failure the best possible outcome.

Key takeaways

This study evaluates a new setting for heart failure devices.
It aims to improve heart function more effectively.
Participants will have a specific type of heart device.
You'll be randomly assigned to one of two treatment groups.
The study involves follow-up visits over 12 months.
Your ongoing heart care will not be affected if you join or leave.

Who may be eligible?

To join this study, you generally need to be at least 18 years old and willing to follow the study's plan. You must be getting a new CRT device from a specific brand (Abbott) as a first-time implant or an upgrade from an older device, and never had a wire placed in your left heart chamber before. Your heart failure needs to be moderate to severe, despite taking your regular heart medication for at least three months.

Your heart's main pumping chamber (left ventricle) should not be pumping blood at full strength (doctors call this an LVEF of 35% or less), and you must have a specific type of abnormal heart rhythm called a Left Bundle Branch Block (LBBB) on your ECG. Also, the electrical signals between the upper and lower chambers of your heart need to be working properly.

There are also some reasons why you might not be able to join. For example, if you've recently had a heart attack, certain heart procedures like angioplasty or surgery, a stroke, or other heart treatments in the last few months. You also can't have certain ongoing or frequent irregular heartbeats (like permanent or persistent AF, or frequent paroxysmal AF).

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 18 years or older?
Are you getting an Abbott CRT device (new or as an upgrade)?
Have you been diagnosed with moderate to severe heart failure?
Is your heart's main pumping chamber not fully effective (LVEF 35% or less)?
Do you have a specific heart rhythm problem called Left Bundle Branch Block (LBBB)?
Have you avoided recent heart attacks, strokes, or certain heart procedures?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have your new CRT device implanted. Within 2-6 weeks after that, you'll be randomly assigned to one of two groups. If you're in the SyncAV ON group, doctors will do some special tests to find the best SyncAV setting for your heart. If you're in the standard settings group, your device will be programmed with the usual settings.

You'll have follow-up visits at 3, 6, and 12 months after your device is set up. During these visits, doctors will collect important information about your heart. If you're in the SyncAV ON group, your device settings will be re-checked and fine-tuned again at the 3 and 6-month visits. The total duration of your participation in the study, including all follow-up visits, will be about 12 months after your device is programmed.

Potential risks and benefits

Taking part in this study could offer a potential benefit if the SyncAV ON feature proves to be more effective than standard settings, leading to better long-term improvements in your heart function. However, as with any medical procedure or device, there are always some risks involved, even though these are routine procedures that would happen whether you are in the study or not. You will receive careful monitoring throughout the study. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (104)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Heart Center Research, LLC.
Verified postcode
Huntsville, United States
Arizona Cardiovascular Research Center
Verified postcode
Phoenix, United States
HonorHealth
Verified postcode
Scottsdale, United States
Comprehensive Cardiovascular
Verified postcode
Bakersfield, United States
Cardiovascular Consultants Heart Center
Verified postcode
Fresno, United States
USC University Hospital
Verified postcode
Los Angeles, United States
Colorado Heart & Vascular, P.C.
Verified postcode
Lakewood, United States
Shands at the University of Florida
Verified postcode
Gainesville, United States
Heart Rhythm Solutions
Verified postcode
Hollywood, United States
Piedmont Heart Institute
Verified postcode
Atlanta, United States
Emory University Hospital
Verified postcode
Atlanta, United States
Iowa Heart Center
Verified postcode
West Des Moines, United States

Common questions

What is a CRT device?

A CRT device is a type of pacemaker that helps the different parts of your heart beat in a more coordinated way, especially if you have heart failure. This helps your heart pump blood more effectively.

What is SyncAV ON?

SyncAV ON is a new, smart feature on some CRT devices. It's designed to automatically adjust how the device sends signals to your heart to make the beats even more in sync and improve pumping.

Will I know which group I'm in?

Because people are chosen by chance (randomised), you won't get to choose which group you're in, and in some studies, participants may not know which treatment they are receiving to keep the results fair.

What kind of visits will I have?

You'll have visits after your device is implanted, and then at 3, 6, and 12 months. During these visits, doctors will check your general health and your device settings.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point. Your decision will not affect the medical care you receive.