Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-20 @ 11:21 PM
Study NCT ID:
NCT03085667
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2016-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline atrial natriuretic Peptide (ANP)', 'timeFrame': '24 h post intervention', 'description': 'comparison of ANP level pre and post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Left atrial appendage occluder', 'Watchman device', 'Atrial fibrillation', 'atrial natriureitc peptide', 'brain natriuretic peptide'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Closure of the LAA by several devices is a alternative therapy to oral anticoagulation in patients with Atrail fibrillation. Nothing is known about the acute influence of a device closure of the LAA on the secretion of ANB nad BNP hormones. Therefore aim of our study is to measure ANB and BNP levvels before and after Implantation of an LAA closure device.', 'detailedDescription': 'ANB and BNP levels are measured before, directly after and late after 24 h in central or periphereal venous blood from patients undergoing interventional LAA closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing left atrial appendage closure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing LAA closure\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03085667', 'briefTitle': 'Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life', 'orgStudyIdInfo': {'id': 'SMW 05'}}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Heart Center Leipzig- University Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Sven Möbius-Winkler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Sven Möbius-Winkler', 'investigatorAffiliation': 'University of Leipzig'}}}}