Continued Safety and Performance of the TIVUS System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01835535
Recruitment Status : Unknown
Verified March 2014 by Cardiosonic.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hypertension, Resistant to Conventional Therapy Device: TIVUS Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension
Study Start Date : August 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Severe Resistant HTN
Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater
Device: TIVUS

Primary Outcome Measures :
  1. Change in office Systolic Blood Pressure (SBP) from baseline to 6-month [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Procedural complications [ Time Frame: 30 day ]
  2. Major Adverse Events (MAE) [ Time Frame: 1 year ]
  3. Preservation of renal function [ Time Frame: 1 year ]
  4. Cardiovascular complications [ Time Frame: 1 year ]
  5. Blood pressure reduction [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01835535

Royal Perth Hospital
Perth, Australia
Sponsors and Collaborators
Principal Investigator: Michael Jonas, MD Kaplan Medical Center

Responsible Party: Cardiosonic Identifier: NCT01835535     History of Changes
Other Study ID Numbers: CLN02-001
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases