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Hypertension

Reduce HTN: Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE

Short Description: Hypertension, also known as high blood pressure, is a long term medical condition in which the blood pressure in the arteries is persistently elevated. Despite the availability of numerous safe and effective drugs that treat hypertension, the percentage of patients achieving adequate blood pressure control to guideline target values remains low, leaving uncontrolled patients at an increased cardiovascular risk. Currently the first line treatments for hypertension are recommendations for lifestyle modification and the use of antihypertensive medication. Guidelines typically recommend the use of one or two drugs of different classes but despite the well documented ability of hypertensive drugs to reduce blood pressure, particularly in combination, hypertension remains uncontrolled in as much as 50% of patients in the United States.

The REDUCE HTN trial is investigating an alternative treatment to HTN without medication. It is a multi-center, prospective, single armed, randomized, controlled, study evaluating the safety and efficacy of renal denervation using the Vessix Renal Denervation System in subjects for the treatment of uncontrolled hypertension. The purpose is to demonstrate that Vessix Reduce Catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension in patients with systolic blood pressure greater than or equal to 150 mmHg and less than or equal to 180mmHg. All subjects will be followed up at 2, 4 and 8 weeks and 3, 4, 5, 6, 12, 18, 24, 30 and 36 months after the procedure. The trial will enroll up to 100 subjects and will be conducted at up to 15 actively enrolling study centers. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Ajay Kirtane, MD

https://clinicaltrials.gov/ct2/show/NCT02392351?term=reduce+htn&rank=3

Sponsor: Boston Scientific

Radiance HTN: The “RADIANCE-HTN” Study A study of the ReCor Medical Paradise System in Clinical Hypertension

Short Description: This study is looking at an alternative to medications by using the investigational device, Paradise Renal Denervation System, for treating patients with high blood pressure. The Paradise Renal Denervation System will be used in this renal denervation procedure to treat hypertension that can not be controlled by medication. It works by disabling the arterial nerves and lowering blood pressure. There are 46 participating sites within the US, up 9 patient can be enrolled in either the Solo or Trio arm of the study not exceeding the sample size of 292 patients. Patient follow up visits will be at 1, 2, 3, 4, 5, 6, 12, 24 and 36 months post-procedure date. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Ajay Kirtane, MD

https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance+htn&rank=1

Sponsor: Recor Medical

 

 

 

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