Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot* Ablation System.
- Conditions
- high blood pressure10057166hypertension10082206
- Registration Number
- NL-OMON37812
- Lead Sponsor
- Maya Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1. Systolic blood pressure >= 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications taken at optimal dose amounts including a diuretic and that has been stable for two weeks prior to screening.
2. Age 18-85 years
3. Able to provide informed consent and comply with follow-up visits
1. Diameter of left or right renal artery less then 4mm or greater then 7mm.
2. Length of treatable segment of renal artery less than 20mm.
3. Renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty.
4. End-stage renal disease requiring dialysis or renal transplant
5. eGFR < 45 mL/min per 1.73 m2
6. Type 1 diabetes mellitus
7. Myocardial infarction, unstable angina, or cerebrovascular events within 6 months prior to screening
8. Severe valvular heart disease for which reduction of blood pressure would be considered hazardous
9. Bleeding disorder or refusing blood transfusions
10. Pregnancy or breast feeding
11. Peripheral vascular disease precluding catheter insertion
12. Any serious medical condition, which in the opinion of the investigator, may adversely affect the safety or effectiveness of the participant or the study
13. Current enrollment in another investigational drug or device
Study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. RDN Acute Safety, defined as overall rate of Serious Adverse Events (SAE*s)<br /><br>and adverse device effects at discharge:<br /><br>(a) SAE*s related to groin and vascular access complications, and<br /><br>(b) SAE*s related to renal artery injury<br /><br>2. RDN Chronic Safety, defined as the overall rate of Serious Adverse Events<br /><br>and Adverse Device Effects at 6 months<br /><br>3. RDN Effectiveness, defined as Office Systolic Blood Pressure (SBP) reduction<br /><br>>10 mmHg at 6 months compared to baseline</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Procedure time<br /><br>2. Fluoroscopy time<br /><br>3. Rate of Office SBP reduction >=10mmHg at 12, 24 and 36 months compared to<br /><br>baseline.</p><br>