Clinical trial NCT01705080: IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
Official title: IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension
Blood Pressure
Keywords: Renal Denervation
Renal artery
EnligHTN™ Renal Denervation System
Renal Artery Ablation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with uncontrolled hypertension

Brief summary: The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

Detailed description: This is a post market, prospective, multicenter, non-randomized, single arm study of the EnligHTN™ Renal Denervation System. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located internationally and will be followed up to five years post procedure.

Eligibility criteria: Inclusion Criteria:

* 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 ≥ 140 mmHg at confirmatory visit
* Subject has a daytime mean Systolic Ambulatory Blood Pressure \> 135 mmHg within 90 days prior to procedure
* Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is on a guideline based drug regimen at a stable and fully tolerated dose consisting of ≥ 3 anti-hypertensive medications (including 1 diuretic) or subject has a documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.

Exclusion Criteria:

* Subject has 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 hemodynamically significant valvular heart disease as determined by study investigator
* Subject has a life expectancy less than 12 months, as determined by the Investigator
* Subject is participating in another clinical study which has the potential to impact their 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 renal arteries with diameter(s) \< 4 mm in diameter
* Subject has an estimated GFR \<15 mL/min per 1.73 m\^2 using the MDRD formula
* Subject had a renal transplant or is awaiting a renal transplant
* Subject has blood clotting abnormalities

Primary outcomes:
measure: Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
timeFrame: 30 days post procedure
measure: Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months
timeFrame: 6 months
measure: Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months
timeFrame: Confirmatory visit to 6 months
measure: Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years
timeFrame: 2 years
measure: Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years
timeFrame: 5 years
measure: Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years
timeFrame: Confirmatory visit to 2 years
measure: Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years
timeFrame: Confirmatory visit to 5 years
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months
timeFrame: Baseline to 6 months
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months
timeFrame: Baseline to 6 months
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months
timeFrame: Baseline to 6 months
measure: Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months
timeFrame: 6 months
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation
timeFrame: Baseline to 1 year
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation
timeFrame: Baseline to 2 years
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation
timeFrame: Baseline to 3 years
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation
timeFrame: Baseline to 4 years
measure: Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation
timeFrame: Baseline to 5 years
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
timeFrame: Baseline to 1 year
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
timeFrame: Baseline to 2 years
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
timeFrame: Baseline to 3 years
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
timeFrame: Baseline to 4 years
measure: Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
timeFrame: Baseline to 5 years
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation
timeFrame: Baseline to 1 year
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation
timeFrame: Baseline to 2 years
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation
timeFrame: Baseline to 3 years
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation
timeFrame: Baseline to 4 years
measure: Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation
timeFrame: Baseline to 5 years
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
timeFrame: Baseline to 1 year
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
timeFrame: Baseline to 2 years
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
timeFrame: Baseline to 3 years
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
timeFrame: Baseline to 4 years
measure: Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Parkville
country: Australia
facility: Royal Melbourne Hospital - City Campus
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Besancon
country: France
facility: CHU de Besancon - Jean Minjoz
state: Franche-Comte
city: Paris
country: France
facility: Institute Cardio. Paris-Sud-Institut Jacques Cartier
state: Massy
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: St. Etienne
country: France
facility: St-Etienne CHU
city: Strasbourg
country: France
facility: Hopital Civil - Universitaires de Strasbourg
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
state: Bavaria
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt GmbH
state: Bavaria
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik gGmbH
state: Hesse
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
state: Nordrhein Westfalen
city: Leipzig
country: Germany
facility: Uni-Klinik Leipzig, Intervent. Angiologie
state: Saxony
city: Bad Krozingen
country: Germany
facility: Universitats-Herzzentrum Freiburg - Bad Krozingen
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus Berlin
city: Essen
country: Germany
facility: Universitatsklinikum Essen (AoR)
city: Homburg
country: Germany
facility: Universitatsklinikum des Saarlandes
city: Mainz
country: Germany
facility: Klinikum der Johannes-Gutenberg-Universitat
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Bruder
city: Athens
country: Greece
facility: University of Athens, Ippocration Hospital
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio CNR
state: Tuscany
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis Locatie Leyenburg
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Dunedin
country: New Zealand
facility: Dunedin Public Hospital
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Basque
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital Gothenburg
city: London
country: United Kingdom
facility: NIHR Barts Cardiovascular Biomedical Research Unit
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: NIHR Barts Cardiovascular Biomedical Research Unit
name: Melvin Lobo, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Adelaide Hospital
name: Stephen Worthley, MB BS PhD
role: PRINCIPAL_INVESTIGATOR
References: