Viewing Study NCT02006758

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 12:26 AM
Ignite Modification Date: 2026-02-21 @ 9:44 PM
Study NCT ID: NCT02006758
Status: COMPLETED
Last Update Posted: 2019-10-16
First Post: 2013-12-05
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Observational Study of the EnligHTN Renal Denervation System in Europe
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bahrain', 'Greece', 'Saudi Arabia']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rebecca.maslow@abbott.com', 'phone': '+1 651-756-5564', 'title': 'Rebecca Maslow, MA, Clinical Project Manager', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over 12 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 5, 'seriousNumAtRisk': 68, 'deathsNumAffected': 1, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arterial Hypertension/Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bacterial Infections of the Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Drug Side Effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sustained Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Viral Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VASC Vessel Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Office Systolic Blood Pressure at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.6', 'spread': '29.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '58 out of 67 participants analyzed for primary outcome measure of office systolic blood pressure at 6 months.'}, {'type': 'SECONDARY', 'title': 'Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'title': 'Back Pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Renal Artery Stenosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urinary Tract Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Viral Syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Office Systolic Blood Pressure at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.0', 'spread': '28.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '61 out of 67 participants were analyzed for mean reduction in office Systolic Blood Pressure at 1 month.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Office Diastolic Blood Pressure at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Patients', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '16.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '61 out of 67 analyzed for mean change in office Diastolic Blood Pressure at 1 month'}, {'type': 'SECONDARY', 'title': 'Mean Change in Ambulatory Systolic Blood Pressure at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.8', 'spread': '18.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '23 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 1 month'}, {'type': 'SECONDARY', 'title': 'Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.6', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '23 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 1 month.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '62 out of 67 participants analyzed for percentage of subjects achieving office Systolic Blood Pressure \\< 140 mmHg at 1 month.'}, {'type': 'SECONDARY', 'title': 'Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '21.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mL/min per 1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '48 out of 67 analyzed for renal function change based on eGFR at 6 months.'}, {'type': 'SECONDARY', 'title': 'Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '21.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'unitOfMeasure': 'mL/min per 1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '38 out of 67 analyzed for renal function change based on eGFR at 12 months.'}, {'type': 'SECONDARY', 'title': 'Renovascular Safety at 6 Months (Renal Artery Stenosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Office Systolic Blood Pressure at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.8', 'spread': '24.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 out of 67 participants analyzed for mean change in office Systolic Blood Pressure at 12 months.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Office Diastolic Blood Pressure at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '17.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '58 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 6 months'}, {'type': 'SECONDARY', 'title': 'Mean Change in Office Diastolic Blood Pressure at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'spread': '16.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '54 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 12 months'}, {'type': 'SECONDARY', 'title': 'Mean Change in Ambulatory Systolic Blood Pressure at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.8', 'spread': '13.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '29 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 6 months'}, {'type': 'SECONDARY', 'title': 'Mean Change in Ambulatory Systolic Blood Pressure at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.4', 'spread': '19.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '25 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 12 months'}, {'type': 'SECONDARY', 'title': 'Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.6', 'spread': '7.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '29 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 6 months'}, {'type': 'SECONDARY', 'title': 'Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.2', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '25 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 12 months'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '59 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure \\< 140 mmHg at 6 months'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '55 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure \\< 140 mmHg at 12 months'}, {'type': 'POST_HOC', 'title': 'Serum Creatinine Concentration at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '227.9', 'spread': '1013.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'umol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '55 out of 67 analyzed for serum creatinine concentration at 6 months.'}, {'type': 'POST_HOC', 'title': 'Serum Creatinine Concentration at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '90.2', 'spread': '29.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'umol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '46 out of 67 analyzed for serum creatinine concentration at 6 months.'}, {'type': 'POST_HOC', 'title': 'Urine Albumin to Creatinine Ratio at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '212.8', 'spread': '635.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'unitOfMeasure': 'mg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '17 out of 67 analyzed for serum creatinine concentration at 6 months.'}, {'type': 'POST_HOC', 'title': 'Urine Albumin to Creatinine Ratio at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '179.0', 'spread': '373.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'mg/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 out of 67 analyzed for serum creatinine concentration at 6 months.'}, {'type': 'POST_HOC', 'title': 'Number of Anti-hypertensive Medications Participant Currently Takes at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'unitOfMeasure': 'number of medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '55 out of 67 participants were analyzed for number of anti-hypertensive medications taken at 12 months'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with EnligHTN system for the treatment of uncontrolled hypertension'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Total number of enrolled participants', 'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'Underwent Renal Denervation', 'achievements': [{'comment': 'Underwent renal denervation', 'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': '1-month Follow up', 'achievements': [{'comment': '1-month follow up completed', 'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': '6-month Follow up', 'achievements': [{'comment': '6-month follow up completed', 'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': '12-month Follow up', 'achievements': [{'comment': '12-month follow up completed', 'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Procedurally excluded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Uncontrolled Hypertension Participants', 'description': 'Renal denervation procedure with the EnligHTN System for the treatment of uncontrolled hypertension'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.1', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Estonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Portugal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Physical Assessment - Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88.8', 'spread': '19.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Physical Assessment - Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '169.8', 'spread': '10.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 subject was excluded due to inclusion criteria violation'}, {'title': 'Physical assessment - Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.5', 'spread': '5.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Hypertension (HTN)', 'classes': [{'title': 'Years since HTN diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '11.5', 'groupId': 'BG000'}]}]}, {'title': 'Years since subject was on anti-HTN meds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11.1', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were not collected for all participants.'}, {'title': 'Renal artery atherosclerosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Renal artery atherosclerosis percentage', 'classes': [{'title': 'Percentage (%) of atherosclerosis on the right', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '0.0', 'groupId': 'BG000'}]}]}, {'title': 'Percentage (%) of atherosclerosis on the left', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': '2 participants had renal artery atherosclerosis, of which both were located on the right side.', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage (%)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 participants had renal artery atherosclerosis, of which both were located on the right side.'}, {'title': 'Renovascular Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Other Renal Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Cardiovascular History', 'classes': [{'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Coronary Artery Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Coronary Artery Bypass Graft', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Percutaneous Coronary Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Abdominal Aortic Aneurysm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Valvular Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Arrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Cardiomyopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded because of inclusion criteria violation.'}, {'title': 'Neurological history', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Cerebrovascular accident', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Additional Medical History', 'classes': [{'title': 'Hyperlipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Significant Alcohol intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Office Blood Pressure', 'classes': [{'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '163.7', 'spread': '22.5', 'groupId': 'BG000'}]}]}, {'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '90.3', 'spread': '15.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were not collected for all participants.'}, {'title': 'Ambulatory Blood Pressure', 'classes': [{'title': '24 Hour Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '155.0', 'spread': '16.9', 'groupId': 'BG000'}]}]}, {'title': '24 Hour Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '86.6', 'spread': '14.7', 'groupId': 'BG000'}]}]}, {'title': 'Day time Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '158.1', 'spread': '17.1', 'groupId': 'BG000'}]}]}, {'title': 'Day time Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89.2', 'spread': '14.9', 'groupId': 'BG000'}]}]}, {'title': 'Night time Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '149.6', 'spread': '23.6', 'groupId': 'BG000'}]}]}, {'title': 'Night time Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '80.5', 'spread': '16.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were not collected for all participants'}, {'title': 'Heart Rate', 'classes': [{'title': 'Office Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.4', 'spread': '11.7', 'groupId': 'BG000'}]}]}, {'title': '24-Hour Ambulatory Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67.7', 'spread': '12.1', 'groupId': 'BG000'}]}]}, {'title': 'Day time Ambulatory Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70.3', 'spread': '13.5', 'groupId': 'BG000'}]}]}, {'title': 'Night time Ambulatory Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.2', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'bpm (beats per minute)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were not collected for all participants'}, {'title': 'Participants on stable anti-HTN medication prior to enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Number of anti-HTN medications participant currently takes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'medications', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 participant was excluded due to inclusion criteria violation'}, {'title': 'Antiarrhythmic Medication currently being taken', 'classes': [{'title': 'ACE/angiotensin 2 receptor/direct renin inhibitors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Beta blockers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': 'Calcium Channel Blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Diuretics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': 'Other hypertensive medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Please note: Same participant may be on multiple different medications, and counted in each category.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Antihypertensive medication usage information was available for all enrolled participants'}, {'title': 'Serum creatinine concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '86.1', 'spread': '27.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'umol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were not collected for all participants'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '79.1', 'spread': '24.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min per 1.73 m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were not collected for all participants'}, {'title': 'Urine Albumin to Creatinine Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '89.6', 'spread': '235', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/g', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were not collected for all participants'}], 'populationDescription': '67 participants underwent renal denervation; 1 participant was excluded because of inclusion criteria violation'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-03-25', 'size': 1675275, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-18T09:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2013-12-05', 'resultsFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-14', 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Office Systolic Blood Pressure at 6 Months', 'timeFrame': 'Baseline and 6 months'}], 'secondaryOutcomes': [{'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', 'description': 'Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uncontrolled Hypertension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with uncontrolled hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is planned to undergo a renal denervation procedure for the treatment of hypertension\n* Subject is ≥18 years of age at time of consent\n* Subject must be able and willing to provide written informed consent\n* Subject must be able and willing to comply with the required follow-up schedule\n* Subject has office SBP ≥ 140 mmHg\n* 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)\n\nExclusion Criteria:\n\n* Subject has known significant renovascular abnormalities such as renal artery stenosis \\> 30%\n* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts\n* Subject has a history of hemodynamically significant valvular heart disease\n* Subject has blood clotting abnormalities\n* Subject life expectancy is \\< 12 months, as determined by the Study Investigator\n* Subject is participating in another clinical study which has the potential to impact his/her hypertension management (pharmaceutical/ device/ homeopathic)\n* Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods\n* Subject has active systemic infection\n* Subject has known renal arteries with diameter(s) \\< 4 mm\n* Subject has an estimated GFR \\<45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula\n* Subject had a renal transplant or is awaiting a renal transplant'}, 'identificationModule': {'nctId': 'NCT02006758', 'briefTitle': 'Observational Study of the EnligHTN Renal Denervation System in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'EnligHTN European Observational Study', 'orgStudyIdInfo': {'id': 'CV-12-064-EU-HT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Uncontrolled hypertension patients', 'description': "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.", 'interventionNames': ['Device: EnligHTN™ Renal Denervation System']}], 'interventions': [{'name': 'EnligHTN™ Renal Denervation System', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Uncontrolled hypertension patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6042', 'city': 'Lodelinsart', 'state': 'Hainaut', 'country': 'Belgium', 'facility': 'Hôpital Civil Marie Curie', 'geoPoint': {'lat': 50.43138, 'lon': 4.44886}}, {'zip': '13419', 'city': 'Tallinn', 'state': 'Harjuma', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '24068', 'city': 'Alzano Lombardo', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Dr. Gianluigi Patelli', 'geoPoint': {'lat': 45.73681, 'lon': 9.72638}}, {'zip': '20131', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Instituto Clinico Citta Studi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '24040', 'city': 'Osio Sotto', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Policlinico San Marco', 'geoPoint': {'lat': 45.61608, 'lon': 9.58905}}, {'zip': '28100', 'city': 'Novara', 'state': 'Peimonte', 'country': 'Italy', 'facility': 'Clinica San Gaudenzio', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '2795-523', 'city': 'Carnaxide', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'Hospital de Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}, {'zip': '21005', 'city': 'Huelva', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Hospital Juan Ramon Jimenez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clinica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '06010', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hopspital Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '46206', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '36204', 'city': 'Vigo', 'country': 'Spain', 'facility': 'Hospital Xeral-Cies de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': 'BT63 5QQ', 'city': 'Portadown', 'state': 'Nirelnd', 'country': 'United Kingdom', 'facility': 'Craigavon Area Hospital', 'geoPoint': {'lat': 54.42302, 'lon': -6.44434}}], 'overallOfficials': [{'name': 'José Diaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Juan Ramon Jimenez, Huelva, Spain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}