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.
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.
Study Type
OBSERVATIONAL
Enrollment
25
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Kliniken Oberallgäu gGmbH Klinik Immenstadt
Immenstadt im Allgäu, Bavaria, Germany
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany
Mean Reduction in Office Systolic Blood Pressure at 6 Months
Positive number indicates a reduction (improvement) in blood pressure
Time frame: 6 months
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Klinikum Ernst von Bergmann
Potsdam, Brandenburg, Germany
Asklepios Schwalm-Eder-Kliniken GmbH
Schwalmstadt, Hesse, Germany
Klinikum Oldenburg gGmbH
Oldenburg, Lower Saxony, Germany
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Elisabeth-Krankenhaus Essen
Essen, North Rhine-Westphalia, Germany
Kardiologische Praxis Wuppertal
Wuppertal, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
...and 2 more locations