Continued Safety and Performance of the TIVUS System

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01835535
• Other study ID #: CLN02-001
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 17, 2013
• Last updated: March 25, 2014
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2014
• Source: Cardiosonic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Device:
• TIVUS

Locations

Country	Name	City	State
Australia	Royal Perth Hospital	Perth

Sponsors (1)

Lead Sponsor	Collaborator
Cardiosonic

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in office Systolic Blood Pressure (SBP) from baseline to 6-month		6 month	No
Secondary	Procedural complications		30 day	Yes
Secondary	Major Adverse Events (MAE)		1 year	Yes
Secondary	Preservation of renal function		1 year	Yes
Secondary	Cardiovascular complications		1 year	Yes
Secondary	Blood pressure reduction		1 year	No