RENABLATE Feasibility - EC12-02

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01756300
First received: December 20, 2012
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

The RENABLATE study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.


Condition Intervention Phase
Renal Denervation
Hypertension
Procedure: Renal Sympathetic Denervation
Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Non Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure. [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: Yes ]
    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.

  • Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure [ Time Frame: From baseline to 12 months post-procedure ] [ Designated as safety issue: No ]
    This secondary effectiveness endpoint is defined as Change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure

  • 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 [ Time Frame: From baseline to 12 months post-procedure ] [ Designated as safety issue: No ]
    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.

  • Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]
    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).

  • 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: 12 months post-procedure ] [ Designated as safety issue: No ]
    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


Enrollment: 35
Study Start Date: December 2012
Study Completion Date: April 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistant Hypertension Procedure: Renal Sympathetic Denervation Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter

  Eligibility

Ages Eligible for Study:   19 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756300

Locations
Australia, Victoria
Peninsula Heart Centre
Frankston, Victoria, Australia, 3199
Belgium
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Czech Republic
Charles University Hospital
Prague, Czech Republic, 12808
Na Homolce Hospital
Prague, Czech Republic, 15 030
Denmark
Aarhus University Hospital, Skejby Sygehus
Aarhus, Denmark, 8200
Italy
Ospedale Generale Regionale
Bari, Italy
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01756300     History of Changes
Other Study ID Numbers: RENABLATE
Study First Received: December 20, 2012
Results First Received: July 27, 2015
Last Updated: July 27, 2015
Health Authority: Czech Republic: SUKL
Belgium: AFMPS
Denmark: Danish Health and Medicines Authority
Germany: BfArM
Italy: AIFA
Australia: Therapeutic Goods Administration (TGA)

Keywords provided by Biosense Webster, Inc.:
Essential Hypertension
Renal Denervation
Vascular Disease
Renal Catheter Ablation
Primary Hypertension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015