Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-01 @ 3:51 PM
Study NCT ID:
NCT01680757
Status:
WITHDRAWN
Last Update Posted:
2013-02-25
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study has been withdrawn prior to enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of procedural success', 'timeFrame': 'Baseline', 'description': 'Exploratory objectives include assessment of the rate of procedural success (defined as completion of the procedure as intended at baseline, as assessed by the clinical site Principal Investigator)'}, {'measure': 'Rate of complications', 'timeFrame': 'During 1 year follow-up', 'description': 'Exploratory objectives include assessment of the rate of complications related to the use of the LARIAT and accessories'}], 'primaryOutcomes': [{'measure': 'Rate of complete exclusion', 'timeFrame': 'During 1 year follow-up.', 'description': 'To assess the rate of complete exclusion of the left atrial appendage (defined as \\< 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Left Atrial Appendage', 'LARIAT', 'atrial fibrillation', 'contraindication to oral anticoagulation therapy'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥ 21 years\n2. Diagnosed non-valvular atrial fibrillation\n3. Current CHADS2 score \\> 2\n4. Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile INR level (While on anticoagulation therapy, participant had INR results "out of therapeutic range" \\> 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).\n5. Life expectancy of at least 1 year\n6. Willing and able to return and comply with scheduled follow up visits\n7. Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Prior cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)\n2. Prosthetic heart valve or ring in any position\n3. Current NYHA Class IV heart failure symptoms\n4. Current right heart failure\n5. Myocardial infarction within last 3 months\n6. Unstable angina within last 3 months\n7. Current cardiogenic shock or hemodynamic instability\n8. Current symptomatic carotid disease\n9. Need for an intra-aortic balloon pump or intravenous inotropes\n10. Embolic stroke within the last 30 days\n11. Transient ischemic attack (TIA) within the last 30 days\n12. Current diagnosis of active systemic infection\n13. eGFR \\< 60 mL/min/1.73m2 within last 3 months\n14. Current renal failure requiring dialysis\n15. ALT or AST level \\> 3 times upper level of normal, indicating hepatic failure. (NOTE: normal range provided by local laboratory performing the measurement), based on most recent pre-procedure assessment (within 30 days of study treatment)\n16. Current clinical evidence of cirrhosis\n17. Any history of thoracic radiation\n18. Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases\n19. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)\n20. Any history of pericarditis\n21. Pectus excavatum (clinically defined by treating physician)\n22. Severe scoliosis\n23. Thrombocytopenia (platelet count \\< 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment)\n24. Anemia with hemoglobin concentration of \\< 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment)\n25. Pregnancy or desire to get pregnant within next 12 months.\n26. Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry\n27. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study\n28. Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)'}, 'identificationModule': {'nctId': 'NCT01680757', 'acronym': 'PLACE III', 'briefTitle': 'Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)', 'orgStudyIdInfo': {'id': 'RS-001 PLACE III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAA exclusion with LARIAT & Accessories', 'description': 'Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories', 'interventionNames': ['Device: LARIAT Suture Delivery Device and Accessories']}], 'interventions': [{'name': 'LARIAT Suture Delivery Device and Accessories', 'type': 'DEVICE', 'otherNames': ['LARIATTM Suture Delivery Device', 'ENDOCATH Occlusion Balloon', 'SOFTIPTM Guide Cannula', 'FINDRWIRZ Guide Wire System', 'SURECUT Suture Cutter', 'TENSURE Suture Puller'], 'armGroupLabels': ['LAA exclusion with LARIAT & Accessories']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Good Samaritan', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Green Hospital and Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94122', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Hospital and Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cardiac Arrhythmia Research Foundation', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Heart Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital Research Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '60327', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Cardiovascular Center Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '31202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'John Paul II Hospital', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Gregory Marcus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}