Continued Safety and Performance of the TIVUS System

Cardiosonic

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Hypertension, Resistant to Conventional Therapy

Treatments

Device: TIVUS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01835535

CLN02-001

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)