Continued Safety and Performance of the TIVUS System

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension

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

Study Overview

• Status: Unknown
• Conditions: Hypertension, Resistant to Conventional Therapy
• Intervention / Treatment: Device: TIVUS

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • Perth, Australia
    • Royal Perth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month	6 month

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Cardiosonic
• Investigators: Principal Investigator: Michael Jonas, MD, Kaplan Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 18, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CLN02-001