RELIVE - Clinical Trial
What is the Purpose of this Study?
If you decide to join this study, doctors will first check your medical history and the medicines you are taking to see if you can be part of it. If you qualify, you will have several tests, including:
- A heart scan (CT or MRI)
- An ultrasound of your heart
- A full check-up, including your heart and brain if you had a stroke before
- Blood tests to check things like salt levels, kidney and liver health, and heart function
- A heart test called an ECG
- A walking test to see how far you can walk in 6 minutes
- A survey called the Kansas City Cardiomyopathy Questionnaire to learn how you feel
Some visits may take a long time, up to 8 hours.
This study is testing a special device called the Revivent System to help people with heart failure. Heart failure happens when the heart cannot pump blood as well as it should. Some people with heart failure have damaged areas in their heart called scars or aneurysms, especially in the front part of the heart.
The Revivent System works by making the heart smaller and stronger. It uses tiny anchors to close off the damaged parts of the heart so the healthy parts can work better. This may help people:
- Live longer
- Stay out of the hospital
- Avoid needing a heart transplant or a heart pump
- Feel better and do more everyday activities
Doctors hope this device will improve the quality of life for people with heart failure without needing open-heart surgery.
Who Can Participate in the Study?
To be part of this study, a person must meet several rules:
- They must be 18 years old or older.
- They must have a problem with their heart called a scar or aneurysm in a certain part of the heart.
- The scar must be in the front, tip, or side of the heart.
- Other parts of the heart must still be working well.
- Their heart must not be pumping very strongly.
- Their heart must be holding a large amount of blood after it pumps.
- They must have signs of heart failure that affect their daily life.
- They must have been taking the right heart medicine for at least 3 months.
- They must have taken a walking test and filled out a health survey.
- They or someone they trust must sign a paper saying they agree to be in the study.
- They must agree to come back for check-ups.
- If the person is a woman who could have children, she must not plan to get pregnant for at least one year. She must also take a pregnancy test before a certain part of the study.
What is Involved?
This study is testing a special device called the BioVentrix Revivent System to help people with heart failure. Some people in the study will get this device along with regular heart medicine, and others will get only the regular medicine. Doctors want to see which treatment works better.
The device is used to treat damaged areas of the heart, especially in the front and bottom parts. These damaged areas are called scars or aneurysms. The goal is to help the heart work better and make people feel healthier.
Doctors will check how safe the device is and how well it helps the heart over time. People in the study will be watched closely and have regular check-ups.
Study Details
