N/A
N=50
Rapid Renal Sympathetic Denervation for Resistant Hypertension
Hypertension, Resistant to Conventional Therapy
Bottom Line
View on ClinicalTrials.gov: NCT01520506 ↗Enrolled (actual)
50
Serious AEs
32.0%
Results posted
Sep 2015
Primary outcome: Primary: Acute Procedural Safety — 4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Covidien OneShot™ System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Procedural Safety |
4 | — |
| SECONDARY Chronic Procedural Safety |
6 | — |
| SECONDARY Renal Denervation Procedure Effectiveness |
61.7 | — |
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.
Eligibility Criteria
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.
- Bleeding disorder or refusing blood transfusions.
- Pregnancy or breast feeding.
- Peripheral vascular disease precluding catheter insertion.
- Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study.
- Current enrollment in another investigational drug or device Study.
Data sourced from ClinicalTrials.gov (NCT01520506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.