Continued Safety and Performance of the TIVUS System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cardiosonic
ClinicalTrials.gov Identifier:
NCT01835535
First received: April 17, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Hypertension, Resistant to Conventional Therapy
Device: TIVUS
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cardiosonic:

Primary Outcome Measures:
  • Change in office Systolic Blood Pressure (SBP) from baseline to 6-month [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedural complications [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
  • Major Adverse Events (MAE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Preservation of renal function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiovascular complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Blood pressure reduction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835535

Locations
Australia
Royal Perth Hospital
Perth, Australia
Sponsors and Collaborators
Cardiosonic
Investigators
Principal Investigator: Michael Jonas, MD Kaplan Medical Center
  More Information

No publications provided

Responsible Party: Cardiosonic
ClinicalTrials.gov Identifier: NCT01835535     History of Changes
Other Study ID Numbers: CLN02-001
Study First Received: April 17, 2013
Last Updated: March 25, 2014
Health Authority: Israel: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Switzerland: Swissmedic

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014