Safety and Effectiveness of Left Atrial Appendage Occlusion
NCT ID: NCT00567515
Last Updated: 2013-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2007-09-30
2012-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
NCT05478304
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment
NCT03732794
Stroke Feasibility Study
NCT01997905
Left Atrial Appendage Ligation Using the Atriclip Device
NCT03759418
Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III
NCT01680757
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LAA Clip
AtriCure LAA Exclusion System
AtriCure LAA Exclusion System
Placement of clip of LAA.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AtriCure LAA Exclusion System
Placement of clip of LAA.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Elective Maze procedure
3. Suitable anatomy
4. Able and willing to sign informed consent
5. Age over 18 years
Exclusion Criteria
1. intra-venous catecholamines
2. ventilator
3. cardiac index \<1.8 l/min.
2. Reoperative Cardiac Surgery
3. Systemic or Inflammatory disease
4. Dialysis
5. Recent myocardial infarction (\< 21 days)
6. History of pericarditis
7. Patient taking part in any other device or drug study
8. Patient with known sensitivity or allergy to any of the device components
9. Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AtriCure, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michele Genoni, MD, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Zurich
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Caliskan E, Sahin A, Yilmaz M, Seifert B, Hinzpeter R, Alkadhi H, Cox JL, Holubec T, Reser D, Falk V, Grunenfelder J, Genoni M, Maisano F, Salzberg SP, Emmert MY. Epicardial left atrial appendage AtriClip occlusion reduces the incidence of stroke in patients with atrial fibrillation undergoing cardiac surgery. Europace. 2018 Jul 1;20(7):e105-e114. doi: 10.1093/europace/eux211.
Emmert MY, Puippe G, Baumuller S, Alkadhi H, Landmesser U, Plass A, Bettex D, Scherman J, Grunenfelder J, Genoni M, Falk V, Salzberg SP. Safe, effective and durable epicardial left atrial appendage clip occlusion in patients with atrial fibrillation undergoing cardiac surgery: first long-term results from a prospective device trial. Eur J Cardiothorac Surg. 2014 Jan;45(1):126-31. doi: 10.1093/ejcts/ezt204. Epub 2013 May 8.
Salzberg SP, Plass A, Emmert MY, Desbiolles L, Alkadhi H, Grunenfelder J, Genoni M. Left atrial appendage clip occlusion: early clinical results. J Thorac Cardiovasc Surg. 2010 May;139(5):1269-74. doi: 10.1016/j.jtcvs.2009.06.033. Epub 2009 Nov 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OUS 2007-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.