Maya Renal Hypertension Ablation System Study

Not Applicable

Completed

• Conditions: hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12611000987965
• Lead Sponsor: Maya Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified