Continued Safety and Performance of the TIVUS System
Phase 2
- Conditions
- Hypertension, Resistant to Conventional Therapy
- Interventions
- Device: TIVUS
- Registration Number
- NCT01835535
- Lead Sponsor
- Cardiosonic
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Severe Resistant HTN TIVUS Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater
- Primary Outcome Measures
Name Time Method Change in office Systolic Blood Pressure (SBP) from baseline to 6-month 6 month
- Secondary Outcome Measures
Name Time Method Blood pressure reduction 1 year Procedural complications 30 day Major Adverse Events (MAE) 1 year Cardiovascular complications 1 year Preservation of renal function 1 year
Trial Locations
- Locations (1)
Royal Perth Hospital
🇦🇺Perth, Australia