Status:
UNKNOWN
Continued Safety and Performance of the TIVUS System
Lead Sponsor:
Cardiosonic
Conditions:
Hypertension, Resistant to Conventional Therapy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 Re...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01835535
Start Date
August 1 2013
End Date
December 1 2016
Last Update
March 26 2014
Active Locations (1)
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1
Royal Perth Hospital
Perth, Australia