A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension

Date Added
September 24th, 2019
PRO Number
Pro00091232
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

This is a study for patients with high blood pressure. The purpose of this study is to evaluate the safety and effectiveness of renal denervation while you are still on your blood pressure medications. Renal denervation is a procedure that destroys the nerve fibers that run along the kidney blood vessels interrupting nerve signals that may cause high blood pressure.The purpose of the treatment (renal denervation) is to lower blood pressure. You will undergo renal angiography (RA), which you may or may not receive the study treatment (depending upon your study assignment). The sponsor has manufactured a new drug/device combination product called the Peregrine Systemâ„¢ Kit (also referred to as the Peregrine Kit). The Peregrine Kit contains a device, the Peregrine Systemâ„¢ Infusion Catheter (also referred to as the Peregrine Catheter), and a drug dehydrated alcohol for injection (also referred to as alcohol). Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces your blood pressure. The participant will be asked to return to the doctor's office for follow-up visits at 4 and 8 weeks, 3, 4, 5 and 6 months, and 1, 2, and 3 years after the procedure. At the 1 year visit, the participant will find out if he/she got the treatment, and if he/she did not, they can choose to cross-over to the treatment if they still meet eligibility criteria.

Institution
MUSC
Recruitment Contact
Anthony Awkar
8438765009
awkar@musc.edu

Repository of Phase Signals for Pulmonary Hypertension Algorithm Development

Date Added
September 10th, 2019
PRO Number
Pro00089125
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular
Summary

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. .

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu

Building a Repository of Cardiac Phase Signals for Algorithm Development Recruiting Mostly Female Subjects

Date Added
September 10th, 2019
PRO Number
Pro00088809
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository of heart signals from eligible subjects. The experimental part of this study is the collection of the participant's 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, then compared to the results of the participant's heart catheterization and saved for future research and development activities sponsored by Analytics 4 Life. The study will include up to 2500 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.

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu

The "RADIANCE II" Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension

Date Added
October 9th, 2018
PRO Number
Pro00081841
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

The purpose of this clinical 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 FDA. Renal denervation is a procedure where a catheter is placed inside these blood vessels (renal arteries). The 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.

Participants will stop taking hypertensive medication before the procedure and up to two months after the procedure. Participants will be randomized to the procedure or control and will be followed for 36 months. At the six month follow-up appointment, participants will learn whether they had the procedure or not. Those who did not receive the procedure can opt in to have the procedure in the future.

Institution
MUSC
Recruitment Contact
Vijay Paladugu
8438765009
paladugc@musc.edu



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