Overview

This trial is active, not recruiting.

Condition hypertension, resistant to conventional therapy
Treatment tivus
Phase phase 2/phase 3
Sponsor Cardiosonic
Start date August 2013
End date June 2014
Trial size 80 participants
Trial identifier NCT01835535, CLN02-001

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater
tivus

Primary Outcomes

Measure
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
time frame: 6 month

Secondary Outcomes

Measure
Procedural complications
time frame: 30 day
Major Adverse Events (MAE)
time frame: 1 year
Preservation of renal function
time frame: 1 year
Cardiovascular complications
time frame: 1 year
Blood pressure reduction
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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)

Additional Information

Official title Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension
Principal investigator Michael Jonas, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Cardiosonic.