CompletedPhase 1

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

35 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range19 Years – 84 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is \> 18 and \< 85 years old.
✓. Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
✓. 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.
✓. 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

✕. Subjects with known/diagnosed secondary hypertension.
✕. Subject has 'White Coat' hypertension defined as 24 hour daytime systolic blood pressure \<135 mm Hg as evaluated at Baseline visit.
✕. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter.
✕. Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
✕. Subject has multiple main renal arteries in either kidney.
✕. Subject has a history of prior renal artery intervention including balloon angioplasty, stenting or surgery.
✕. Subject had a previous kidney transplant or is a planned recipient of a transplant kidney or is on dialysis.
✕. Subject has a past history of unilateral kidney removal or has a solitary functional kidney for any other reason.

What they're measuring

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

Timeframe: 30 days post-procedure

Trial details

NCT IDNCT01756300

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2015-07-27

View on ClinicalTrials.gov More Hypertension, Renal trials