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:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT01996033
Eligibility Criteria:
Inclusion Criteria:
* Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
* Subject is ≥18 years of age at time of consent
* Subject must be able and willing to provide written informed consent
* Subject must be able and willing to comply with the required follow-up schedule
* Subject has office Systolic Blood Pressure (SBP) ≥ 140 mmHg
* Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs
Exclusion Criteria:
* Subject has known significant renovascular abnormalities such as renal artery stenosis \> 30%
* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
* Subject has a history of hemodynamically significant valvular heart disease
* Subject has blood clotting abnormalities
* Subject life expectancy is \< 12 months, as determined by the Study Investigator
* Subject is participating in another clinical study which has the potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01996033
Study Brief:
Protocol Section:
NCT01996033