Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-29 @ 3:54 PM
Study NCT ID:
NCT01983605
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2013-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Atrial Appendage Exclusion Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2013-11-07', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of device related serious adverse events', 'timeFrame': '30 days'}, {'measure': 'Percent of patients with complete exclusion of the LAA measured with TEE', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Appendage']}, 'referencesModule': {'references': [{'pmid': '23062528', 'type': 'RESULT', 'citation': 'Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov SJ, Lee RJ. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol. 2013 Jul 9;62(2):108-118. doi: 10.1016/j.jacc.2012.06.046. Epub 2012 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.', 'detailedDescription': 'The objective of this study is to evaluate the safety and effectiveness of the SentreHEART suture delivery system for the exclusion of the left atrial appendage in up to 100 treated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is greater than or equal to 18 years of age\n2. Subject has atrial fibrillation (paroxysmal or persistent)\n3. Subject is poor candidate for Warfarin (contraindicated, labile INR, non-compliant)\n4. Subject is willing and able to provide written informed consent\n5. Subject has a life expectancy of at least 1 year\n6. Subject is willing and able to return for scheduled follow up visits\n\nExclusion Criteria:\n\n1. Previous cardiac surgery\n2. Thrombus in the left atrial appendage or left atrium\n3. NYHA Class IV heart failure symptoms\n4. Need for emergent cardiac surgery (i.e. cardiogenic shock)\n5. LAA is not appropriate for exclusion based upon intraoperative evaluations\n6. Current diagnosis of active systemic infection\n7. Renal failure requiring dialysis or hepatic failure\n8. A known drug and/or alcohol addiction\n9. Mental impairment or other conditions, which may not allow subject to understand the nature, significance and scope of the study\n10. Pregnancy or desire to get pregnant within 12 months of the study treatment\n11. Preoperative need for an intra-aortic balloon pump or intravenous inotropes\n12. Patients who have been treated with thoracic radiation\n13. Patients in current chemotherapy\n14. Patients on long-term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.\n15. Patients with known connective tissue disorders, i.e. Lupus\n16. Previous history of pericarditis\n17. Presence of a PFO/ASD or valve implant'}, 'identificationModule': {'nctId': 'NCT01983605', 'acronym': 'PLACE II', 'briefTitle': 'Left Atrial Appendage Exclusion Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AtriCure, Inc.'}, 'officialTitle': 'Left Atrial Appendage Exclusion Study II', 'orgStudyIdInfo': {'id': 'RS-001 V3.0_120709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'LAA exclusion with the LARIAT Suture Delivery Device', 'interventionNames': ['Device: LARIAT Suture Delivery Device']}], 'interventions': [{'name': 'LARIAT Suture Delivery Device', 'type': 'DEVICE', 'description': 'LAA exclusion procedure', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian University (John Paul II) Hospital', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Jerzy Sadowski, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University (John Paul II) Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}