Observational Study of the EnligHTN Renal Denervation System in Europe
NCT ID: NCT02006758
Last Updated: 2019-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
68 participants
OBSERVATIONAL
2013-11-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Uncontrolled hypertension patients
The study will enroll 500 patients planned to undergo a renal denervation procedure (with the 'EnligHTN™ Renal Denervation System') for the treatment of their uncontrolled hypertension.
EnligHTN™ Renal Denervation System
The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).
Interventions
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EnligHTN™ Renal Denervation System
The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).
Eligibility Criteria
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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 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 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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José Diaz, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Juan Ramon Jimenez, Huelva, Spain
Locations
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Hôpital Civil Marie Curie
Lodelinsart, Hainaut, Belgium
North Estonia Medical Centre
Tallinn, Harjuma, Estonia
Dr. Gianluigi Patelli
Alzano Lombardo, Lombardy, Italy
Instituto Clinico Citta Studi
Milan, Lombardy, Italy
Policlinico San Marco
Osio Sotto, Lombardy, Italy
Clinica San Gaudenzio
Novara, Peimonte, Italy
Hospital de Santa Cruz
Carnaxide, Lisbon District, Portugal
Hospital Juan Ramon Jimenez
Huelva, Andalusia, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hopspital Infanta Cristina
Badajoz, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Xeral-Cies de Vigo
Vigo, , Spain
Craigavon Area Hospital
Portadown, Nirelnd, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CV-12-064-EU-HT
Identifier Type: -
Identifier Source: org_study_id
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