Hypertension, RenalPhase 1RENABLATE-IINCT02095691
RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
A Phase 1 study testing Celsius® ThermoCool® Renal Denervation in people with Hypertension, Renal, run by Biosense Webster, Inc..
Trial summary
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Renal
- What is being tested?
- Celsius® ThermoCool® Renal Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Apr 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines.
- Subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.
- Subject is > 18 and < 85 years of age.
- Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.
Who cannot join
- A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
- Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
- Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.
- Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.
- Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD formula.
- Subject has type 1 diabetes mellitus.
- Subject has history of Myocardial Infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques.
- Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
About this study
Official title: A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)
This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.
- Conditions
- Hypertension, Renal
- Being tested
- Celsius® ThermoCool® Renal Denervation
- Keywords
- Renal Sympathetic Denervation
- Medical subject headings
- Hypertension, Renal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celsius® ThermoCool® Renal DenervationDevice
Also called Multi-electrode Ablation Catheter
The investigational device is indicated for the treatment of resistant hypertension by renal denervation.
| Study group | Role | What they receive |
|---|---|---|
| Resistant Hypertension | Experimental | The Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension. Receives: Device: Celsius® ThermoCool® Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.
Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.
Measured: 30 days post-procedure
Secondary outcomes (4)
Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit
These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.
Measured: 12 months post-procedure
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.
Measured: 12 months post-procedure
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.
Measured: 12 months post-procedure
Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertension, RenalStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095691
- Sponsor's protocol ID
- RENABLATE-II
- Acronym
- RENABLATE-II
- Status last verified
- Jan 2025
- First submitted
- 21 Mar 2014
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)
- ClinicalTrials.gov ID
- NCT02095691
- Acronym / sponsor ID
- RENABLATE-II / RENABLATE-II
- Conditions
- Hypertension, Renal
- Keywords
- Renal Sympathetic Denervation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 7 Dec 2015
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, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant Hypertension | Experimental | Device: Celsius® ThermoCool® Renal DenervationThe Celsius® ThermoCool® Renal Denervation catheter will serve to treat resistant hypertension. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines.
- Subject is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.
- Subject is > 18 and < 85 years of age.
- Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.
Key exclusion criteria (8 listed)
- A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
- Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
- Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.
- Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.
- Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD formula.
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 |
|---|---|---|
| Celsius® ThermoCool® Renal DenervationAlso: Multi-electrode Ablation CatheterThe investigational device is indicated for the treatment of resistant hypertension by renal denervation. | Device | Resistant Hypertension |
Primary outcome
Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.
Time frame: 30 days post-procedure
Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.
4 secondary outcomes
Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit
Time frame: 12 months post-procedure
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
Time frame: 12 months post-procedure
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Time frame: 12 months post-procedure
Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure
Time frame: 12 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celsius® ThermoCool® Renal Denervation in people with Hypertension, Renal, run by Biosense Webster, Inc..
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 4 inclusion and 8 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure. (time frame: 30 days post-procedure). 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 4 Feb 2025.