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

April 17, 2013
March 25, 2014
August 2013
June 2014   (final data collection date for primary outcome measure)
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01835535 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension, Resistant to Conventional Therapy
Device: TIVUS
Experimental: Severe Resistant HTN
Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater
Intervention: Device: TIVUS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2016
June 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01835535
CLN02-001
No
Cardiosonic
Cardiosonic
Not Provided
Principal Investigator: Michael Jonas, MD Kaplan Medical Center
Cardiosonic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP