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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Reduction in Office Systolic Blood Pressure at 6 Months | Positive number indicates a reduction (improvement) in blood pressure | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Office Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 6 Months |
| Reduction in Office Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure |
Inclusion Criteria:
Exclusion Criteria:
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The patient population enrolled in this investigation will consist of males and females with uncontrolled hypertension who meet all inclusion criteria, and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Christoph K Naber, MD | Elisabeth-Krankenhaus Essen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Villingen-Schwenningen | Villingen-Schwenningen | Baden-Wurttemberg | 78052 | Germany | ||
| Kliniken Oberallgäu gGmbH Klinik Immenstadt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Cohort | All subjects - this is a single arm study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Cohort | All subjects - this is a single arm study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Reduction in Office Systolic Blood Pressure at 6 Months | Positive number indicates a reduction (improvement) in blood pressure | All subjects with data available at baseline and 6-month follow up | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Full Cohort | All subjects - this is a single arm study | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate Disease | Reproductive system and breast disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Hypertension/Hypertension | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Madej | Abbott | 651-756-2230 | steven.madej@abbott.com |
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| 12 Months |
| Reduction in Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months |
| Reduction in 24 Hour Ambulatory Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months |
| Reduction in 24 Hour Ambulatory Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months |
| Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 1 Month |
| Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 6 Months |
| Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | 12 Months |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Change from baseline in eGFR | 12 Months |
| Immenstadt im Allgäu |
| Bavaria |
| 87509 |
| Germany |
| Immanuelklinikum Bernau und Herzzentrum Brandenburg | Bernau bei Berlin | Brandenburg | 16321 | Germany |
| Klinikum Ernst von Bergmann | Potsdam | Brandenburg | 14467 | Germany |
| Asklepios Schwalm-Eder-Kliniken GmbH | Schwalmstadt | Hesse | 34613 | Germany |
| Klinikum Oldenburg gGmbH | Oldenburg | Lower Saxony | 26133 | Germany |
| Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Elisabeth-Krankenhaus Essen | Essen | North Rhine-Westphalia | 45138 | Germany |
| Kardiologische Praxis Wuppertal | Wuppertal | North Rhine-Westphalia | 42103 | Germany |
| Universitätsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| Augusta-Krankenhaus Düsseldorf | Düsseldorf | 40472 | Germany |
| Diakonie-Klinikum Schwäbisch Hall gGmbH | Schwäbisch Hall | 74523 | Germany |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Years since HTN diagnosis | Some subjects were missing baseline data. | Mean | Standard Deviation | years |
|
| Years taking anti-HTN medications | Some subjects were missing baseline data. | Mean | Standard Deviation | years |
|
| Myocardial Infarction | Count of Participants | Participants |
|
| Coronary Artery Disease | Count of Participants | Participants |
|
| Coronary Artery Bypass Graft | Count of Participants | Participants |
|
| Percutaneous Coronary Intervention | Count of Participants | Participants |
|
| Cerebrovascular Accident | Count of Participants | Participants |
|
| Obstructive Sleep Apnea | Count of Participants | Participants |
|
| Diabetes (Type II) | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Height | Mean | Standard Deviation | centimeters |
|
| BMI | Mean | Standard Deviation | kilograms/meter2 |
|
| Office Blood Pressure | Mean | Standard Deviation | mmHg |
|
| 24Hr Ambulatory Blood Pressure | Some subjects were missing baseline data. | Mean | Standard Deviation | mmHg |
|
| Serum Creatinine | Mean | Standard Deviation | micromoles/liter |
|
| Estimated Glomerular Filtration Rate | Mean | Standard Deviation | mL/min per 1.73m2 |
|
| Number of Antihypertensive Medications | Mean | Standard Deviation | medications |
|
| Heart Rate | Some subjects were missing baseline data. | Mean | Standard Deviation | beats per minute |
|
|
| Other Pre-specified | Reduction in Office Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Mean | Standard Deviation | mmHg | 6 Months |
|
|
|
| Other Pre-specified | Reduction in Office Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Mean | Standard Deviation | mmHg | 12 Months |
|
|
|
| Other Pre-specified | Reduction in Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Mean | Standard Deviation | mmHg | 12 Months |
|
|
|
| Other Pre-specified | Reduction in 24 Hour Ambulatory Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Mean | Standard Deviation | mmHg | 12 Months |
|
|
|
| Other Pre-specified | Reduction in 24 Hour Ambulatory Diastolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Mean | Standard Deviation | mmHg | 12 Months |
|
|
|
| Other Pre-specified | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Count of Participants | Participants | 1 Month |
|
|
|
| Other Pre-specified | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Count of Participants | Participants | 6 Months |
|
|
|
| Other Pre-specified | Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure | Positive number indicates a reduction (improvement) in blood pressure | Subjects with baseline and follow up data available | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| Other Pre-specified | Change in Estimated Glomerular Filtration Rate (eGFR) | Change from baseline in eGFR | Subjects with both baseline and follow up data available | Posted | Mean | Standard Deviation | mL/min per 1.73m2 | 12 Months |
|
|
|
| 25 |
| 5 |
| 25 |
| 4 |
| 25 |
| Arterial Hypertension/Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Multiple Organ Failure | General disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypertensive Crisis | Vascular disorders | Non-systematic Assessment |
|
| VASC Vessel Stenosis | Vascular disorders | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | Non-systematic Assessment |
|
| Abnormal Lab Value (Suspicion of Cholangitis) | Hepatobiliary disorders | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Renal Artery Stenosis | Vascular disorders | Non-systematic Assessment |
|
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