None listed
Conditions
Brief summary
An initial evaluation of the Maya Renal Hypertension Ablation System for the treatment of subjects with chronic resistant hypertension
Interventions
Balloon Catheter delivers low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney. The treatment time is approximately 2 minutes. Catheter is removed from the body at the end of procedure.
Sponsors
Maya Medical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject has a systolic blood pressure greater than or equal to 160 mmHg Subject is on 2 or more anti hypertensive medications Bilateral Renal Arteries must be between 4-7mm diameter and greater than 20mm in length Subject signs informed consent and agrees to follow up visits
Exclusion criteria
Subject has a glomerular filtration rate (eGFR) of < 45mL/min/1.73m2, using the MDRD calculation. Subject has had a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit. Subject has history of bleeding diathesis or coagulopathy, Type 1 diabetes, renal artery stenosis, valve disease, planned surgery or intervention in coming 6 months, allergy to listed drugs in protocol, is pregnant, or has peripheral disease precluding a 9F sheath introducer.
Outcome results
None listed