RecruitingOBSERVATIONAL

Prospective WCD Post CABG Registry (CABG Registry)

This study is gathering information on people who have their first heart bypass surgery. Doctors want to see how many of them completely recover their heart's pumping ability (known as ventricular function) after the surgery. These patients will be given a wearable cardioverter defibrillator (WCD) to wear after they leave the hospital, as part of their usual care. The main goal is to find out if using improved medication regularly helps more people recover their heart function compared to what has been seen in the past. It's an observational study, meaning researchers will simply watch and record what happens, rather than actively giving new treatments.

At a glance

Status

Recruiting

Sponsor

Zoll Medical Corporation

Enrolment target

910

Start

23 Sep 2024

Estimated completion

01 May 2030

Cardiomyopathy Ischemic Cardiomyopathies Cardiovascular Diseases Heart Disease, Ischemic

What is this study about?

This research study, called the CABG Registry, is looking into how well people recover after a common heart operation called coronary artery bypass graft (CABG) surgery. This surgery helps improve blood flow to the heart. Doctors are particularly interested in patients whose heart isn't pumping blood as strongly as it should be before the surgery.

After their first CABG surgery, these patients will wear a special device called a Wearable Cardioverter Defibrillator (WCD). This device can detect if the heart has a dangerous rhythm and deliver a shock if needed, much like a regular defibrillator. The study aims to see how many patients wearing this device, and also taking their recommended heart medications, see their heart function improve significantly.

The study hopes to show that with modern, effective medications, more people will see their heart function get much better after surgery. This is important because a stronger heart means a better quality of life and less risk of future heart problems. This is an 'observational' study, which means doctors will be carefully watching and recording patients' progress, rather than testing a brand new treatment.

Key takeaways

This study looks at heart recovery after first-time bypass surgery.
It focuses on patients who wear a special device called a WCD.
Researchers want to see if modern medications help more people recover their heart function.
It's an 'observational' study, so no new treatments are being tested.
Participation involves monitoring your recovery, not new procedures or medications.

Who may be eligible?

To be considered for this study, you would need to have had your first-ever coronary artery bypass graft (CABG) surgery in the last 10 days. After your surgery, and before you leave the hospital, your doctors would have found that your heart's pumping ability (ejection fraction) is reduced to 35% or less, and you would have been given a wearable cardioverter defibrillator (WCD) to wear as part of your standard care. You must also be 18 years old or over.

However, you wouldn't be able to join if you had a combination surgery that involved repairing a heart valve at the same time as your CABG, or if you've had CABG surgery before. You'd also be excluded if you have a specific type of pacemaker (called an active unipolar pacemaker).

Other reasons you couldn't take part include having a physical or mental condition that would make it hard for you to use the WCD properly, or if you have a skin condition that would prevent you from wearing the device. Finally, if you are currently taking part in another clinical study where you are trying out a new treatment, or if you have a legal document (an advanced directive) clearly stating that you do not wish to be resuscitated, you would not be eligible.

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.

Did you have your first heart bypass surgery less than 10 days ago?
Were you prescribed a wearable cardioverter defibrillator (WCD) after surgery due to reduced heart pumping function?
Are you 18 years old or older?
Have you NOT had a previous heart bypass surgery?
Do you NOT have a physical or mental condition making it hard to use a WCD?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new or experimental treatments. Instead, doctors will simply observe and record information about your recovery after your heart bypass surgery. This includes monitoring how well your heart recovers its pumping ability while you are wearing the wearable cardioverter defibrillator (WCD) and taking your usual heart medications. The study will mainly involve collecting information that is already part of your routine medical care after surgery. You won't need extra hospital visits or assessments specifically for the study beyond what your doctor would normally recommend. The total duration of your participation will be for the period you are prescribed to wear the WCD.

Potential risks and benefits

As this is an observational study, meaning you won't be trying a new medication or treatment, the direct risks from being in the study itself are very low. All your care, including wearing the WCD and taking medications, is part of your standard treatment. There are no direct benefits to you from participating, beyond contributing to medical knowledge that may help other patients in the future. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (4)

Kerckhoff Klinik
Verified postcode
Bad Nauheim, Germany· Not yet recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting
Sana-Herzzentrum Cottbus GmbH
Verified postcode
Cottbus, Germany· Recruiting
Universitätsklinikum Halle (Saale)
Verified postcode
Halle, Germany· Recruiting

Common questions

What is a WCD?

A WCD is a Wearable Cardioverter Defibrillator. It's a device you wear on your body that can detect dangerous heart rhythms and deliver an electrical shock if needed, similar to an emergency defibrillator.

What is CABG surgery?

CABG stands for Coronary Artery Bypass Graft surgery. It's an operation to improve blood flow to your heart by bypassing blocked or narrowed arteries.

What does 'ejection fraction' (EF) mean?

Ejection fraction is a measurement of how well your heart pumps blood with each beat. A lower number means your heart isn't pumping as strongly as it should.

Will I have to take new medications for this study?

No, this study doesn't involve new medications. You will continue to take the guideline-recommended medications that your doctor has prescribed for your heart condition.

Is this study testing a new treatment?

No, this is an observational study. Researchers are simply gathering information about the recovery of patients who are already receiving standard care, including wearing a WCD and taking regular medications.

How to find out more

Lars Weber, M.Sc.

lweber@zoll.com 015161140498 Official trial record

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