Continued Safety and Performance of the TIVUS System

NCT01835535 | Unknown Phase 2

• 1 other identifier: CLN02-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (1)

• Change in office Systolic Blood Pressure (SBP) from baseline to 6-month

  6 month

Secondary Outcomes (5)

• Procedural complications

  30 day

• Major Adverse Events (MAE)

  1 year

• Preservation of renal function

  1 year

• Cardiovascular complications

  1 year

• Blood pressure reduction

  1 year

Study Arms (1)

Severe Resistant HTN

EXPERIMENTAL

Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater

Device: TIVUS

Interventions

TIVUS DEVICE

Severe Resistant HTN

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiosonic: lead

Study Sites (1)

Royal Perth Hospital

Perth, Australia

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

• Michael Jonas, MD

  Kaplan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 19, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2016
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

AU (1)