CompletedNot Applicable

Rapid Renal Sympathetic Denervation for Resistant Hypertension

Belgium, Germany50 participantsStarted 2012-05

Plain-language summary

The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.

Who can participate

Age range18 Years – 85 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

✓. Systolic blood pressure ≥ 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications that includes a diuretic and that has been stable for 2 weeks prior to screening.
✓. Age 18-85 years.
✓. Able to provide informed consent and comply with follow-up visits.

Exclusion criteria

✕. Diameter of left or right renal artery less than 4 mm or greater than 7mm.
✕. Length of target segment of left or right renal artery less than 20mm.
✕. Other renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
✕. End-stage renal disease requiring dialysis or renal transplant.
✕. estimated Glomerular Filtration Rate \< 45 mL/min per 1.73 m2.
✕. Type 1 diabetes mellitus.
✕. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening.
✕. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous.

What they're measuring

Acute Procedural Safety

Timeframe: One Week

Trial details

NCT IDNCT01520506

SponsorMedtronic Endovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2015-07-31

View on ClinicalTrials.gov More Hypertension, Resistant to Conventional Therapy trials