Active not recruitingNAINTERVENTIONAL

BioVentrix Revivent TC™ System Clinical Study

This research study, called the BioVentrix Revivent TC System Clinical Study, is for people whose left ventricle (the main pumping chamber of the heart) is weakened and has scar tissue on it. The study aims to see if a new device, the Revivent TC System, can help improve heart function and symptoms. It involves two groups: one group will receive the new device, and another group will continue with their usual medical care. Researchers will carefully compare these groups to understand how effective and safe the Revivent TC System is over 12 months. They are looking for people aged 18 to 100 years old, male or female, who meet certain heart health criteria.

At a glance

Status

Active not recruiting

Phase

Sponsor

BioVentrix

Enrolment target

126

Start

29 Aug 2017

Estimated completion

30 Jun 2027

Ventricular Dysfunction, Left

What is this study about?

This clinical study is investigating a new treatment for a heart condition where the main pumping chamber, called the left ventricle, is weakened and has developed scar tissue. This condition can make it hard for your heart to pump blood effectively, leading to symptoms like tiredness or shortness of breath. The new treatment being studied is called the BioVentrix Revivent TC System.

The Revivent TC System is designed to help reshape the left ventricle by excluding the scarred areas. The study will compare patients who receive this new device with those who continue with standard medical care guided by their doctors. This comparison helps the researchers understand if the new device can improve how your heart works and reduce your symptoms over time. They will follow participants closely for at least a year to check for any changes.

By comparing the two groups, the study hopes to gather important information about whether the Revivent TC System is a safe and effective option for people with this type of heart problem. The study is particularly interested in patients whose scar tissue affects specific parts of their left ventricle, as confirmed by heart scans. Your doctor can help determine if your condition matches what the study is looking for.

Key takeaways

This study is for people with a weakened left ventricle and scar tissue on their heart.
It's testing a new device called the BioVentrix Revivent TC System.
The study compares the new device to standard medical care.
Participants will be followed for at least 12 months.
It aims to see if the device improves heart function and symptoms.
Your eligibility will be carefully checked by the study team.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Your doctor would have confirmed that you have scar tissue on the left side of your heart that needs surgical treatment. This scar tissue must be in specific areas, like the front or the wall separating the heart chambers. Your heart's pumping ability (ejection fraction) also needs to be less than 45%, and you should be experiencing heart failure symptoms that haven't improved with regular medication. You'll also need to be well enough to complete a walking test.

There are also some things that would mean you couldn't join. For example, if you've had certain heart procedures recently, or if the location of your heart scar means the study device wouldn't be suitable for you. If you are a woman who could become pregnant, you shouldn't be planning to get pregnant for at least a year after the procedure. Your medical team will thoroughly check all these details to see if this study is right for you.

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 old or older?
Has your doctor told you that you have scar tissue on the left side of your heart that needs treatment?
Are you experiencing heart failure symptoms that haven't improved with current medications?
Are you able to do a 6-minute walking test?
If you are a woman who could get pregnant, are you able to avoid getting pregnant for at least one year?

Answer every question to see your result.

What does participation involve?

If you join this study, you might receive the new Revivent TC device or continue with standard medical care, depending on which group you are allocated to. Before joining, you will have several tests, including heart scans, a walking test, and questionnaires about your quality of life. If you receive the device, there will be a procedure to implant it.

After starting the study, you will have several follow-up visits with the study team over at least 12 months. These visits will involve check-ups to monitor your heart health, assess your symptoms, and see how you are feeling. You'll also continue to take your prescribed heart medications as advised by your doctor. The study team will explain the exact schedule of visits and tests during the consent process.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to new medical knowledge that could help future patients. If you receive the new device, there is a chance it could improve your heart function and reduce your symptoms, though this is not guaranteed as it is still being tested. As with any medical procedure or treatment, there are potential risks, including those associated with heart surgery or the device itself. The study team will explain all known risks to you in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

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

University of Arizona College of Medicine - Phoenix Banner University Medicine Heart Institute
Verified postcode
Phoenix, United States
Ronald Regan UCLA Medical Center
Verified postcode
Los Angeles, United States
University of California, San Francisco
Verified postcode
San Francisco, United States
Los Robles Hospital & Medical Center
Verified postcode
Thousand Oaks, United States
Baptist Hospital of Maimi
Verified postcode
Miami, United States
Emory University Hospital Midtown
Verified postcode
Atlanta, United States
WellStar Health System
Verified postcode
Marietta, United States
Memorial Medical Center
Verified postcode
Springfield, United States
Terrebonne General Medical Center
Verified postcode
Houma, United States
University of Michigan
Verified postcode
Ann Arbor, United States
University of Minnesota Medical Center
Verified postcode
Minneapolis, United States
Saint Luke's Hospital of Kansas City
Verified postcode
Kansas City, United States

Common questions

What is the 'left ventricle'?

The left ventricle is the strongest chamber of your heart and is responsible for pumping oxygen-rich blood to your body.

What does 'scar presence' mean for my heart?

Heart scar tissue means an area of your heart muscle has been damaged and replaced by non-working tissue, which can reduce its pumping ability.

What is 'Guideline Directed Medical Therapy (GDMT)'?

GDMT refers to the best standard medications and treatments for your heart condition, based on current expert recommendations.

Will I know if I'm getting the new device or standard care?

No, you will not know which group you are in. This helps the researchers get unbiased results about the new device.

How long will I be followed up for in the study?

You will be followed up by the study team for at least 12 months after starting the study.