EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension

Abbott

Status: Completed

Conditions: Uncontrolled Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT01996033

CV-12-064-GE-HT

Details and patient eligibility

About

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.

Full description

This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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