This study is seeking participants with uncontrolled high blood pressure despite taking blood pressure medications. The study is examining an investigational device, meaning not approved for commercial use or sale by the Food and Drug Administration (FDA), called the TIVUS System. TIVUS, or Therapeutic IntraVascular UltraSound (TIVUS™) System, is designed to denervate (deaden) the nerves surrounding the renal arteries (blood vessels going to the kidneys) as a way to help lower blood pressure. Participation in this study will last three years and involve approximately 11 in person visits and 3-4 telehealth visits. Study related procedures include blood pressure monitoring both in clinic and at home, 24 hour ambulatory blood pressure monitoring, questionnaires, blood work, electrocardiogram (ECG), which is a recording of the electrical activity of your heart, CT scan of your kidneys and blood vessels around your kidneys and the renal denervation procedure. Some of the risks include bruising, bleeding, pain or damage to the renal arteries.
This study is for participants who have been diagnosed with a pulmonary embolism or PE. A PE is a blood clot in the lung. This study is comparing the FlowTriever Retrieval/Aspiration System to any commercially available Catheter Directed Thrombolysis system in participants who have a PE and undergo a procedure to remove the clot. Participants will be randomized which means they will be randomly assigned like the flip of a coin to have the procedure done wit the the FlowTriever system or a CDT system. All of the devices being used in this study are FDA approved for this indication. This study involves collecting data from the time of diagnosis through 30 days post procedure. Study participation will last about 30 days.
The purpose of this study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the US Food and Drug Administration (FDA). Renal denervation is a procedure where a catheter is placed inside the blood vessels (renal arteries) that go to the kidneys. Ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels. This is a continued access protocol meaning studies have already been done using this device.
This study is for participants who take 0-2 blood pressure medications but continue to have high blood pressure or for participants who take 3 or more blood pressure medications but continue to have high blood pressure. This is a five year study consisting of in person visits at screening, baseline, pre procedure testing, procedure and visits at 1,2,3,4,5,6,12,24,36,48 and 60 months. Study related testing includes BP measurements including 24 hour blood pressure readings, electrocardiograms (ECG), blood work, urine studies, and CT scans. Risks associated with this study include procedure risks such as pain, bleeding or bruising at the catheter insertion site. There are other study related risks such as risks of blood draws, radiation risk associated with the CT scan and loss of confidentiality.
The purpose of this study is to build a repository (collection) of heart signals from eligible subjects. The experimental part of this study is the collection of heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center and paired with the subject's heart catheterization results for future use in research and development activities sponsored by Analytics 4 Life. The study will include up to 1500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits. .