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 TIVUSâ„¢ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUSâ„¢ 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 range18 Years – 80 Years
SexALL
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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.
✕. 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.
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
. 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.