Uncontrolled HypertensionNCT01699529
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
A study testing Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system in people with Uncontrolled Hypertension, run by Medtronic Vascular at 4 sites in 2 countries.
Trial summary
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2012to Oct 2016
- Phase
- Interventional
- 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
- Individual is ≥ 18 and ≤ 80 years old.
- Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
- Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.
Who cannot join
- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to be pregnant.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
Alfred Hospital
Melbourne, Victoria, 3004
St. Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
Epworth Hospital
Melbourne, Victoria, 3069
About this study
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation systemDevice
The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Not described Receives: Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute safety as measured by procedural complications
Measured: 1 month
Secondary outcomes (1)
Change in Office Systolic Blood Pressure
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Whitbourn, MD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699529
- Sponsor's protocol ID
- 10058715DOC
- Status last verified
- Oct 2016
- First submitted
- 21 Sep 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Whitbourn R, Harding SA, Walton A. Symplicity multi-electrode radiofrequency renal denervation system feasibility study. EuroIntervention. 2015 May;11(1):104-9. doi: 10.4244/EIJV11I1A18.
PubMed 25982652
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
- ClinicalTrials.gov ID
- NCT01699529
- Acronym / sponsor ID
- 10058715DOC
- Conditions
- Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Oct 2012 (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.
This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individual is ≥ 18 and ≤ 80 years old.
- Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
- Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.
Key exclusion criteria (5 listed)
- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to be pregnant.
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 |
|---|---|---|
| Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation systemThe Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator. | Device | Renal Denervation |
Primary outcome
Acute safety as measured by procedural complications
Time frame: 1 month
1 secondary outcome
Change in Office Systolic Blood Pressure
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 25982652Whitbourn R, Harding SA, Walton A. Symplicity multi-electrode radiofrequency renal denervation system feasibility study. EuroIntervention. 2015 May;11(1):104-9. doi: 10.4244/EIJV11I1A18.
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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.
Robert Whitbourn, MD principal investigator
St Vincent's Hospital Melbourne
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system in people with Uncontrolled Hypertension, run by Medtronic Vascular at 4 sites in 2 countries.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute safety as measured by procedural complications (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699529, which also lists 1 linked publication.
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 Oct 2016.