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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Coronary Vasospasm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases

ClinicalTrials.gov processed this record on September 16, 2014