Status:
COMPLETED
Rapid Renal Sympathetic Denervation for Resistant Hypertension
Lead Sponsor:
Medtronic Endovascular
Collaborating Sponsors:
Medtronic - MITG
Meditrial Europe Ltd.
Conditions:
Hypertension, Resistant to Conventional Therapy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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.
Detailed Description
Unique to the OneShot™ ablation system is the ability to deliver the desired helical treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment, eliminating user varia...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01520506
Start Date
May 1 2012
End Date
June 1 2014
Last Update
March 1 2019
Active Locations (14)
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1
Middelheim Hospital
Antwerp, Belgium
2
Ziekenhuis Oost--Limburg
Genk, Belgium, 3600
3
Universitatklinikum
Bonn, Germany
4
Cardiovascular Center Sankt Katharinen
Frankfurt, Germany