Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT02164435
Eligibility Criteria:
Inclusion Criteria:
* Subject must be able and willing to comply with the required follow-up schedule
* Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System
* Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.
Exclusion Criteria:
* Standard CMR exclusions;
* implanted cardiac device
* intracranial metallic implants
* claustrophobia -Gadolinium-specific: estimated GFR \<60 mls/min (usual clinical cut-off is \<30 mls/min).
* Adenosine-specific:
* asthma / reactive airways disease
* \>first degree atrioventricular block
* concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation
* EnligHTN™ Renal Denervation System exclusion criteria:
Subject has an identified cause of secondary hypertension
* Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the MDRD formula
* Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts
* Subject has haemodynamically significant valvular heart disease
* Subject has a life expectancy less than 12 months, as determined by the PI
* Subject is participating in another clinical study Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has renal arteries with diameter(s) \< 4 mm in diameter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02164435
Study Brief:
Protocol Section:
NCT02164435