Hypertension, Resistant to Conventional Therapy
Conditions
Brief summary
The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts: * TIVUS™ Severe Resistant HTN Cohort * TIVUS™ Moderate Resistant HTN Cohort * TIVUS™ Failed RF Therapy Cohort
Interventions
DEVICETIVUS
Sponsors
Cardiosonic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient is ≥ 18 and ≤ 80 years of age * For Cohort A: Documented office systolic blood pressure \> 160 mmHg (\> 150 mmHg for diabetic patients); For Cohort B: Documented office systolic blood pressure \> 140 mmHg (\> 130 mmHg for diabetic patients); For Cohort C: Documented office systolic blood pressure \> 150 mmHg (\> 140 mmHg for diabetic patients) * Documented 24 hour systolic ABPM \> 135 mmHg * Adherence to a stable drug regimen * For patients in Cohort C only: Documented renal denervation procedure with any RF technology 12 months or more prior to screening * Suitable renal artery anatomy * Male or non-pregnant / non-lactating female * Patient understands the nature of the procedure and provides written informed consent * Patient is willing and able to comply with the specified study requirements and follow-up evaluations
Exclusion criteria
* eGFR \< 45mL/min/1.73m2 * Documented primary pulmonary hypertension * Patient experienced \>1 episode of orthostatic hypotension coupled with syncope * Documented indicator of a secondary renal hypertension * History of myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months * Planned major surgery or cardiovascular intervention in the next 6 months * Surgery or cardiovascular intervention in the previous 3 months * Hemodynamically significant valvular heart disease * Severe debilitating lung disease * Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization * Patient has a single functioning kidney * Documented thrombocytopenia, clotting disorders or aortic aneurysms * Moribund patient, or patient with comorbidities limiting life expectancy to less than one year * Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication * Concurrent enrollment in another trial * Main renal arteries \< 4 mm in lumen diameter or \< 20 mm in length * Aorto-renal angle that prevents a safe cannulation of the renal artery * Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure * Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery * Any renal artery stenosis \> 50% by visual assessment * Any renal artery aneurysm in either renal artery * A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in office Systolic Blood Pressure (SBP) from baseline to 6-month | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Procedural complications | 30 day |
| Major Adverse Events (MAE) | 1 year |
| Preservation of renal function | 1 year |
| Cardiovascular complications | 1 year |
| Blood pressure reduction | 1 year |
Countries
Australia
Outcome results
None listed