RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157
Condition: Hypertension, Renal
MeSH terms: Hypertension, Renal; Hypertension
Intervention: Celsius® ThermoCool® Renal Denervation
Intervention description: The investigational device is indicated 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: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Renal Sympathetic Denervation

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood
             pressure readings measured according to the BP guidelines.

          2. 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.

          3. Subject is > 18 and < 85 years of age.

          4. 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:

          1. 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.

          2. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the
             investigational device(s).

          3. Subject has main renal arteries that are < 20 mm in length or < 4 mm in diameter.

          4. Subject has a prior history of any renal artery intervention including but not limited
             to balloon angioplasty, stenting, renal denervation or surgery.

          5. Subject has an estimated glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using
             the MDRD formula.

          6. Subject has type 1 diabetes mellitus.

          7. 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.

          8. Subject has hemodynamically significant valvular heart disease for which reduction of
             blood pressure would be considered hazardous.