Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-05 @ 7:57 AM
Study NCT ID:
NCT03085693
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Left Atrial Appendage Closure on Physical Capacity.
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': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity measured by maximal oxygen consumption', 'timeFrame': 'Baselina, 45 days, 6 months', 'description': 'Change from baseline spiroergometry to 45 days to 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the blood circulation and therefore protects from cardioembolic strokes- It is unclear if the volume reduction of the left atrium leads to a change in exercise capacity or Quality of life.', 'detailedDescription': 'The monocentric trial deals with the endocrinological changes as a result of closure of the left atrial appendage with a internal closure device. Specially, the changes in atrial natriuretic peptide, brain natriuretic peptide and their impact on exercise capacity is on focus of the trial. The trial is planned as a all comers trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients before and after closure of the left atrial appendage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with a indication for LAA closure device Implantation\n\nExclusion Criteria:\n\n* Inability to perform exercise testing'}, 'identificationModule': {'nctId': 'NCT03085693', 'acronym': 'LAAEX', 'briefTitle': 'Impact of Left Atrial Appendage Closure on Physical Capacity.', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Impact of Left Atrial Appendage Closure With a Closure Device on Quality of Life, Physical Capacity and Expression of Atrial Natriuretic Peptide and Brain Natriuretic', 'orgStudyIdInfo': {'id': 'SMW06'}}, 'contactsLocationsModule': {'locations': [{'zip': '07747', 'city': 'Jena', 'country': 'Germany', 'facility': 'University of Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Sven Möbius-Winkler, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Jena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Jena', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Sven Möbius-Winkler', 'investigatorAffiliation': 'University of Jena'}}}}