Hypertension, Resistant to Conventional TherapyPhase 2/3NCT01835535
Continued Safety and Performance of the TIVUS System
A Phase 2/3 study testing TIVUS in people with Hypertension, Resistant to Conventional Therapy, run by Cardiosonic at 1 site in Australia.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- TIVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2013to Dec 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- TIVUS
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVUSDevice
| Study group | Role | What they receive |
|---|---|---|
| Severe Resistant HTN | Experimental | Patients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater Receives: Device: TIVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
Measured: 6 month
Secondary outcomes (5)
Procedural complications
Measured: 30 day
Major Adverse Events (MAE)
Measured: 1 year
Preservation of renal function
Measured: 1 year
Cardiovascular complications
Measured: 1 year
Blood pressure reduction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiosonic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Jonas, MD, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835535
- Sponsor's protocol ID
- CLN02-001
- Status last verified
- Mar 2014
- First submitted
- 17 Apr 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT01835535
- Acronym / sponsor ID
- CLN02-001
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CardiosonicIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Resistant HTN | Experimental | Device: TIVUSPatients presenting with resistant hypertension and office systolic blood pressure of 160 mmHg (150 mmHg for DM) or greater |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIVUS | Device | Severe Resistant HTN |
Primary outcome
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month
Time frame: 6 month
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Jonas, MD principal investigator
Kaplan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TIVUS in people with Hypertension, Resistant to Conventional Therapy, run by Cardiosonic at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in office Systolic Blood Pressure (SBP) from baseline to 6-month (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.