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
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UNKNOWN
PHASE3
90 participants
INTERVENTIONAL
2008-12-31
2012-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Persistent AF
Treatment arm to be compared with historical control.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented long term persistent atrial fibrillation (also known as permanent AF).of at least 3 months duration. Persistent AF is defined as AF which is sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion. Long term persistent AF is defined as continuous AF of greater than three months duration.
* Concomitant indication for open heart surgery for at least one of the following:
* Mitral valve repair or replacement
* Aortic valve repair or replacement
* Tricuspid valve repair or replacement
* Atrial septal defect (ASD) repair
* Patent foramen ovale (PFO) closure
* Coronary artery bypass procedure
* Be able to take anticoagulation therapy (Warfarin / Coumadin®)
* Be able to fulfill study requirements
* Willing and able to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent
Exclusion Criteria
* NYHA class = IV
* Left ventricular ejection fraction (LVEF) measurement \<30%
* Left atrial diameter \> 7.5 cm
* Wolff-Parkinson-White (WPW) Syndrome
* Pregnancy or desire to be pregnant within 1 year of the study treatment
* Myocardial infarction within the previous 6 weeks
* Presence of a previously implanted device (valve, CS leads, or ICD)
* Known allergy, contraindication, or inability to comply with warfarin (Coumadin®) or heparin therapy
* Known allergy or contraindication to complying with anti-arrhythmic (Class IA, IC, III) therapy
* Previous thoracic procedure resulting in sternal opening and/or pericardial opening (e.g., CABG, valve replacement or repair)
* Current diagnosis of active endocarditis, local or systemic infection
* Renal failure requiring dialysis or hepatic failure
* Emergent cardiac surgery (cardiogenic shock)
* Preoperative need for intra-aortic balloon pump, IV inotropes or vasoactive agents
* Currently participating in another clinical research study
* Cerebral vascular accident or transient ischemic attack within previous 180 days or at any time with a documented residual neurological deficit
18 Years
ALL
No
Sponsors
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EndoPhotonix, Inc.
INDUSTRY
Responsible Party
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EndoPhotonix, Inc.
Principal Investigators
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Kirk S. Honour
Role: STUDY_CHAIR
EndoPhotonix, Inc.
Central Contacts
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Other Identifiers
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EP-AF-080808
Identifier Type: -
Identifier Source: org_study_id