Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-15 @ 12:01 PM
Study NCT ID:
NCT01996033
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2013-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension
Sponsor:
Organization:
Raw JSON
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'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Prostate Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial Hypertension/Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'VASC Vessel Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Reduction in Office Systolic Blood Pressure at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a single arm study'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '21.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with data 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'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with baseline and follow up data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Reduction in 24 Hour Ambulatory Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a single arm study'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '13.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with baseline and follow up data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Reduction in 24 Hour Ambulatory Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a single arm study'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '10.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with baseline and follow up data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a single arm study'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Month', 'description': 'Positive number indicates a reduction (improvement) in blood pressure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with baseline and follow up data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a single arm study'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with baseline and follow up data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a single arm study'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with baseline and follow up data available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a 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[{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Full Cohort', 'description': 'All subjects - this is a single arm study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '10.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 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[{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary Artery Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary Artery Bypass Graft', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Percutaneous Coronary Intervention', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cerebrovascular Accident', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Obstructive Sleep Apnea', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes (Type II)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88.0', 'spread': '18.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '171.2', 'spread': '8.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.9', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms/meter2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Office Blood Pressure', 'classes': [{'title': 'Systolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '164.5', 'spread': '20.2', 'groupId': 'BG000'}]}]}, {'title': 'Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '87.8', 'spread': '12.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24Hr Ambulatory Blood Pressure', 'classes': [{'title': 'Systolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '157.1', 'spread': '18.6', 'groupId': 'BG000'}]}]}, {'title': 'Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '83.2', 'spread': '15.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some subjects were missing baseline data.'}, {'title': 'Serum Creatinine', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '88.6', 'spread': '18.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micromoles/liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated Glomerular Filtration Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.8', 'spread': '16.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min per 1.73m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Antihypertensive Medications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'medications', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '71.2', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some subjects were missing baseline data.'}], 'populationDescription': 'All subjects'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2013-11-21', 'resultsFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-05', 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reduction in Office Diastolic Blood Pressure', 'timeFrame': '6 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Reduction in Office Diastolic Blood Pressure', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Reduction in Office Systolic Blood Pressure', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Reduction in 24 Hour Ambulatory Systolic Blood Pressure', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Reduction in 24 Hour Ambulatory Diastolic Blood Pressure', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure', 'timeFrame': '1 Month', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure', 'timeFrame': '6 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure', 'timeFrame': '12 Months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}, {'measure': 'Change in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': '12 Months', 'description': 'Change from baseline in eGFR'}], 'primaryOutcomes': [{'measure': 'Mean Reduction in Office Systolic Blood Pressure at 6 Months', 'timeFrame': '6 months', 'description': 'Positive number indicates a reduction (improvement) in blood pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['uncontrolled hypertension', 'Renal Denervation'], '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 patients with uncontrolled hypertension in clinical routine practice.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', '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 Systolic Blood Pressure (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), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs\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'}, 'identificationModule': {'nctId': 'NCT01996033', 'briefTitle': 'EnligHTN German Observational Study of Renal Denervation for Uncontrolled Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation', 'orgStudyIdInfo': {'id': 'CV-12-064-GE-HT'}}, 'contactsLocationsModule': {'locations': [{'zip': '78052', 'city': 'Villingen-Schwenningen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Kliniken Villingen-Schwenningen', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'zip': '87509', 'city': 'Immenstadt im Allgäu', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Kliniken Oberallgäu gGmbH Klinik Immenstadt', 'geoPoint': {'lat': 47.55996, 'lon': 10.21394}}, {'zip': '16321', 'city': 'Bernau bei Berlin', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Immanuelklinikum Bernau und Herzzentrum Brandenburg', 'geoPoint': {'lat': 52.67982, 'lon': 13.58708}}, {'zip': '14467', 'city': 'Potsdam', 'state': 'Brandenburg', 'country': 'Germany', 'facility': 'Klinikum Ernst von Bergmann', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'zip': '34613', 'city': 'Schwalmstadt', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Asklepios Schwalm-Eder-Kliniken GmbH', 'geoPoint': {'lat': 50.93333, 'lon': 9.21667}}, {'zip': '26133', 'city': 'Oldenburg', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Klinikum Oldenburg gGmbH', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Medizinische Einrichtungen der Universität Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '45138', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '42103', 'city': 'Wuppertal', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Kardiologische Praxis Wuppertal', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '40472', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Augusta-Krankenhaus Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '74523', 'city': 'Schwäbisch Hall', 'country': 'Germany', 'facility': 'Diakonie-Klinikum Schwäbisch Hall gGmbH', 'geoPoint': {'lat': 49.11127, 'lon': 9.73908}}], 'overallOfficials': [{'name': 'Christoph K Naber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elisabeth-Krankenhaus Essen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}