Status:
UNKNOWN
SOLAR & ATRILAZE Atrial Fibrillation Trial
Lead Sponsor:
EndoPhotonix, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 fibrillat...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age at least 18 years
- 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
- Life expectancy \< 1 year
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00734058
Start Date
December 1 2008
End Date
June 1 2012
Last Update
August 13 2008
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