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CompletedNCT01756300Updated Feb 4, 2025Results posted

RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension

A Phase 1 interventional study of Celsius® ThermoCool® RD in Hypertension, Renal, sponsored by Biosense Webster, Inc.. Completed. Open to participants aged 19 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-02-04.

Sponsored by Biosense Webster, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
19 Years to 84 Years
Sex
All
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Study summary

The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to treat resistant hypertension.

Read the detailed description

The RENABLATE feasibility study CS156 (EC12-02) is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of renal artery sympathetic denervation using the investigational Celsius® ThermoCool® Renal Denervation (RD) Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.

02

Conditions studied

  • Hypertension, Renal

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Keywords

  • Essential Hypertension
  • Renal Denervation
  • Vascular Disease
  • Renal Catheter Ablation
  • Primary Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 35 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Biosense Webster, Inc. is the lead sponsor of 65 studies on the registry; 10 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject is > 18 and \< 85 years old.
  2. Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
  3. Individual 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.
  4. Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with known/diagnosed secondary hypertension.
  2. Subject has 'White Coat' hypertension defined as 24 hour daytime systolic blood pressure \<135 mm Hg as evaluated at Baseline visit.
  3. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter.
  4. Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
  5. Subject has multiple main renal arteries in either kidney.
  6. Subject has a history of prior renal artery intervention including balloon angioplasty, stenting or surgery.
  7. Subject had a previous kidney transplant or is a planned recipient of a transplant kidney or is on dialysis.
  8. Subject has a past history of unilateral kidney removal or has a solitary functional kidney for any other reason.
  9. Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula.
  10. Subject has type 1 diabetes mellitus.
  11. 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.
  12. Subject had a significant surgery or cardiovascular intervention in the 6 months period preceding enrollment or is planned to have such a surgery or cardiac intervention in the 6 months period post enrollment.
  13. Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
  14. Subject is taking systemic steroids or chronic daily NSAIDs.
  15. Subject has a known allergy to Aspirin and/or other procedural drugs or contrast agents which in the investigator's opinion excludes him/her from the study.
  16. Subject has a serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (e.g., subjects with active systemic infection, subjects with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, or significant anemia).
  17. Women of childbearing potential with a positive pregnancy test during screening OR women who do not agree to remain on birth control until follow-up at 6 months OR lactating women.
  18. Subject has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
  19. Subject is currently enrolled in another investigational drug or device trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Resistant Hypertension

    The catheter-based (device: Celsius® ThermoCool® RD) renal denervation will serve to treat resistant hypertension.

    Device: Celsius® ThermoCool® RD

Interventions

  • DeviceCelsius® ThermoCool® RD

    The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.

    Also known as: Multi-electrode Ablation Catheter

06

What researchers measure

Primary outcomes

  1. The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.

    The 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.

    Time frame: 30 days post-procedure

Secondary outcomes

  1. Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure

    These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural 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.

    Time frame: 12 months post-procedure

  2. Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure

    This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.

    Time frame: From baseline to 1 ,3, 6 and 12 months post procedure

  3. Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure

    This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.

    Time frame: From baseline to 3, 6 and 12 months post procedure

  4. Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure

    This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).

    Time frame: At 1, 3, 6, and 12 month post-procedure

  5. Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure

    This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure

    Time frame: At 1, 3, 6, and 12 month post-procedure

07

Results

Posted Aug 25, 2015

Participant flow

The study enrollment took approximately 11 months, began in December 2, 2012 and completed on November 4, 2013. A total of 68 subjects were consented and 35 started the renal denervation with the investigational ablation catheter.

Participant flow — Overall Study
MilestoneRenal Sympathetic Denervation
Started35
Completed33
Not completed2
Withdrew: Death1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryThe Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.

The 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.

Time frame:
30 days post-procedure
Reported as:
Number · percentage of participants
The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.
percentage of participantsRenal Sympathetic Denervation
The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.0.0
SecondarySubjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure

These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural 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.

Time frame:
12 months post-procedure
Reported as:
Number · percentage of participants
Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure
percentage of participantsRenal Sympathetic Denervation
Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure74.3
SecondaryActual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure

This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.

Time frame:
From baseline to 1 ,3, 6 and 12 months post procedure
Reported as:
Mean · mmHg
Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure
mmHgBlood Pressures at BaselineBlood Pressures at 1-Month Follow UpBlood Pressures at 3-Month Follow UpBlood Pressures at 6-Month Follow UpBlood Pressures at 12-Month Follow Up
Systolic Office Blood Pressure171.0 ± 10.4161.0 ± 21.1159.7 ± 21.7155.4 ± 15.6151.0 ± 18.7
Systolic Mean Change from BaselineNA ± NA-10.0 ± 21.1-11.3 ± 21.9-15.4 ± 17.6-19.8 ± 20.7
Diastolic Office Blood Pressure95.8 ± 16.388.3 ± 15.087.5 ± 1385.0 ± 11.786.4 ± 15.7
Diastolic Mean Change from BaselineNA ± NA-7.6 ± 13.7-8.3 ± 12.4-10.7 ± 13.5-9.0 ± 12.9
SecondaryActual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure

This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.

Time frame:
From baseline to 3, 6 and 12 months post procedure
Reported as:
Mean · mmHg
Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure
mmHgBlood Pressures at BaselineBlood Pressures at 3-Month Follow UpBlood Pressures at 6-Month Follow UpBlood Pressures at 12-Month Follow Up
Systolic Office Blood Pressure156.0 ± 12.9145.4 ± 17.2142.1 ± 15.6141.2 ± 15.6
Systolic Mean Change from BaselineNA ± NA-9.8 ± 12.7-13.1 ± 15.7-14.7 ± 14.9
Diastolic Office Blood Pressure85.8 ± 12.780.8 ± 10.878.5 ± 11.979.0 ± 11.2
Diastolic Mean Change from BaselineNA ± NA-3.9 ± 8.2-6.8 ± 8.0-7.1 ± 6.7
SecondaryIncidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure

This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).

Time frame:
At 1, 3, 6, and 12 month post-procedure
Reported as:
Number · percentage of participants
Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure
percentage of participantsAt One MonthAt Three MonthAt Six MonthAt Twelve Month
Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure14.818.515.423.1
SecondaryIncidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure

This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure

Time frame:
At 1, 3, 6, and 12 month post-procedure
Reported as:
Number · percentage of participants
Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure
percentage of participantsAt One MonthAt Three MonthAt Six MonthAT Twelve Month
Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure48.148.161.576.9

Adverse events

Collected over Twelve months post procedure. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Renal Sympathetic Denervation—7/35 (20%)23/35 (65.7%)
Most frequent serious events
Most frequent serious events
EventRenal Sympathetic Denervation
Atrial fibrillationCardiac disorders2/35
Renal artery stenosisRenal and urinary disorders2/35
AdenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/35
GastritisGastrointestinal disorders1/35
HypertensionVascular disorders1/35
Lumbar painMusculoskeletal and connective tissue disorders1/35
Sudden deathGeneral disorders1/35
Most frequent other events
Showing 10 of 35
Most frequent other events
EventRenal Sympathetic Denervation
Spasm of arteryVascular disorders4/35
BradycardiaCardiac disorders3/35
HypotensionVascular disorders3/35
Incision site hematomaInjury, poisoning and procedural complications3/35
Renal artery stenosisRenal and urinary disorders3/35
Hypertensive crisisVascular disorders2/35
HypokalaemiaMetabolism and nutrition disorders2/35
Albumin urine highInvestigations1/35
Atrial fibrillationCardiac disorders1/35
BreathlessnessRespiratory, thoracic and mediastinal disorders1/35

Baseline characteristics

All treated subjects who underwent the renal sympathetic denervation procedure.

Age, Continuous
Age, Continuous(years)Renal Sympathetic Denervation
Mean62.5 ± 9.5
Sex: Female, Male
Sex: Female, Male(Participants)Renal Sympathetic Denervation
Female12
Male23
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Renal Sympathetic Denervation
African Descent0
Not African Descent35
Region of Enrollment
Region of Enrollment(participants)Renal Sympathetic Denervation
Czech Republic12
Belgium5
Denmark1
Australia15
Italy2
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01756300
Lead sponsor
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Dec 25, 2012
Start date
Dec 2012
Primary completion
Nov 2013
Completion
Apr 2015
Results posted
Aug 25, 2015
Last update
Feb 4, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Hypertension, Renal

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