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Study 1 of 1 for search of: | "EndoPhotonix, Inc." [Exact] |
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Sponsored by: |
EndoPhotonix, Inc. |
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Information provided by: | EndoPhotonix, Inc. |
ClinicalTrials.gov Identifier: | NCT00734058 |
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
The study will test the safety and effectiveness of the EndoPhotonix™ Laser Ablation Systems to photocoagulate cardiac tissue during cardiac surgery, to create electrical isolation of the pulmonary veins and create other electrical isolation lesions in order to treat atrial fibrillation. The surgical procedure will be conducted during concomitant mitral valve repair or replacement surgery or in combination with other cardiac surgery including aortic valve surgery, tricuspid valve surgery, or coronary artery bypass surgery.
Condition | Intervention | Phase |
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Atrial Fibrillation |
Device: Laser MAZE by Ablation of Cardiac Tissue |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery |
Estimated Enrollment: | 90 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Persistent AF: Experimental
Treatment arm to be compared with historical control.
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Device: Laser MAZE by Ablation of Cardiac Tissue
The protocol calls for the creation of the pulmonary vein isolation lesion through the use of the SOLAR™. The additional lesions are to be created using the ATRILAZE™. At surgeon discretion, the ganglia may be ablated and left and right atrial appendages may be removed.
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The study objective is to generate Level II controlled data to support the expansion of indications for the SOLAR™ System based on 0-30 day data; as well as to support the expansion of indications for the SOLAR™ System and ATRILAZE™ System for the treatment of atrial fibrillation based on 180 days data. The data will be evaluated by comparing post-operative data to the historical control data. The subjects in the study cohort will receive laser ablation therapy using the investigational device during a concomitant surgical procedure.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Concomitant indication for open heart surgery for at least one of the following:
Exclusion Criteria:
Contact: Kirk S. Honour | 651-452-3000 | khonour@endophotonix.com |
Contact: Cory H. White | cwhite@endophotonix.com |
Study Chair: | Kirk S. Honour | EndoPhotonix, Inc. |
Responsible Party: | EndoPhotonix, Inc. ( Kirk S Honour, Sr. Vice President ) |
Study ID Numbers: | EP-AF-080808 |
Study First Received: | August 11, 2008 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00734058 |
Health Authority: | United States: Food and Drug Administration |
Ablation AF Atrial Fibrillation Cardiac Endocardial Endocardium EP Electrophysiology Epicardial Epicardium Heart |
Interventional Lesion PVI Pulmonary Vein MAZE Surgery Surgical Treatment Patients with persistent AF with 3 months duration Requiring concomitant open heart surgery |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |