REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study / (NCT05372679) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
REDUCED 1 - Renal Denervation Using Ultrasonic Catheter EmitteD Energy Study /
United States25 participantsStarted 2022-11-11
Plain-language summary
This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
. Male or female, ≥ 18 years of age and ≤ 80 years of age at the time of screening.
. Individual has office systolic blood pressure (SBP) ≥ 140 mm Hg but \< 180 mm Hg, and a diastolic blood pressure (DBP) ≥ 90 mm Hg but \< 110 mm Hg based on an average of 3 office seated blood pressure readings measured by a manual, automated or semi-automated validated BP monitor, on current medications. 4. Documented mean daytime ABPM systolic blood pressure (SBP) ≥ 135 mm Hg but \< 180 mm Hg, after a 4 week stabilization period.
Exclusion criteria
. Patient has been previously diagnosed with abnormal renal artery anatomy and/or renal anatomy such as single kidney, other renal development anomaly such as ectopic or horseshoe kidney, or polycystic kidney disease precluding renal denervation therapy as detailed in the angiographic exclusion criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events
Timeframe: from baseline to 1 month post procedure
2
Incidence of Adverse Events
Timeframe: from baseline to 12 month post procedure
3
Change in mean daytime ambulatory systolic BP
Timeframe: From baseline to 3 months post procedure
. Pregnant or breastfeeding women or women planning a pregnancy within 12 months of study enrollment.
. Patient has an estimated glomerular filtration rate (eGFR) of \< 40mL/min/1.73m2 CKD-EPI as calculated using the CKD-EPI 2021 equation.
. Patients with uncontrolled rapid AF.
. Patient has had a previous renal denervation procedure.
. Patients with daytime ABPM mean systolic blood pressure (SBP) \> 180 mm Hg.
. Patient has Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c \> 9%).
. Patients with history of myocardial infarction, unstable angina pectoris, heart failure, cerebrovascular accident, or widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.