Clinical trial NCT02006758: Observational Study of the EnligHTN Renal Denervation System in Europe
Official title: EnligHTN European Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uncontrolled Hypertension
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with uncontrolled hypertension

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

Detailed description: The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.

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 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)

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 to impact his/her hypertension management (pharmaceutical/ device/ homeopathic)
* Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has active systemic infection
* Subject has known renal arteries with diameter(s) \< 4 mm
* Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
* Subject had a renal transplant or is awaiting a renal transplant

Primary outcomes:
measure: Mean Change in Office Systolic Blood Pressure at 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure
timeFrame: 30 days
measure: Mean Change in Office Systolic Blood Pressure at 1 Month
timeFrame: Baseline and 1 month
measure: Mean Change in Office Diastolic Blood Pressure at 1 Month
timeFrame: Baseline and 1 month
measure: Mean Change in Ambulatory Systolic Blood Pressure at 1 Month
timeFrame: Baseline and 1 month
measure: Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month
timeFrame: Baseline and 1 month
measure: Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month
timeFrame: 1 month
measure: Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months
timeFrame: Baseline and 6 months
measure: Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months
timeFrame: Baseline and 12 months
measure: Renovascular Safety at 6 Months (Renal Artery Stenosis)
timeFrame: 6 months
measure: Mean Change in Office Systolic Blood Pressure at 12 Months
timeFrame: Baseline and 12 months
measure: Mean Change in Office Diastolic Blood Pressure at 6 Months
timeFrame: Baseline and 6 months
measure: Mean Change in Office Diastolic Blood Pressure at 12 Months
timeFrame: Baseline and 12 months
measure: Mean Change in Ambulatory Systolic Blood Pressure at 6 Months
timeFrame: Baseline and 6 months
measure: Mean Change in Ambulatory Systolic Blood Pressure at 12 Months
timeFrame: Baseline and 12 months
measure: Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months
timeFrame: Baseline and 6 months
measure: Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months
timeFrame: Baseline and 12 months
measure: Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months
timeFrame: 6 months
measure: Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Lodelinsart
country: Belgium
facility: Hôpital Civil Marie Curie
state: Hainaut
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
state: Harjuma
city: Alzano Lombardo
country: Italy
facility: Dr. Gianluigi Patelli
state: Lombardia
city: Milano
country: Italy
facility: Instituto Clinico Citta Studi
state: Lombardy
city: Osio Sotto
country: Italy
facility: Policlinico San Marco
state: Lombardy
city: Novara
country: Italy
facility: Clinica San Gaudenzio
state: Peimonte
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
state: Lisbon
city: Huelva
country: Spain
facility: Hospital Juan Ramon Jimenez
state: Andalucia
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Badajoz
country: Spain
facility: Hopspital Infanta Cristina
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Vigo
country: Spain
facility: Hospital Xeral-Cies de Vigo
city: Portadown
country: United Kingdom
facility: Craigavon Area Hospital
state: Nirelnd
Study officials:
affiliation: Hospital Juan Ramon Jimenez, Huelva, Spain
name: José Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References: