RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension
Condition: Hypertension, Renal
MeSH terms: Hypertension, Renal; Hypertension
Intervention: Celsius® ThermoCool® RD
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 19 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Essential Hypertension; Renal Denervation; Vascular Disease; Renal Catheter Ablation; Primary Hypertension

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.
    

Eligibility 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.