SOLAR & ATRILAZE Atrial Fibrillation Trial
SAAF-T
Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery
1 other identifier
interventional
90
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 atrial-fibrillation
Started Dec 2008
Typical duration for phase_3 atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedAugust 13, 2008
August 1, 2008
3.1 years
August 11, 2008
August 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom from atrial fibrillation by 24-hour 3-lead Holter Monitor at the 180 day evaluation. On or Off Class 1 and III anti-arrhythmic medication
180 days
Acute SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
0 through 30 days or length of stay
Secondary Outcomes (2)
SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
180 days
Determine binary freedom from AF, independent of anti-arrhythmic status as documented by 24 hour 3-Lead Holter Monitor. Reduction of AF burden with assumption of 100% initial burden. To establish improvement in Quality of Life.
180 days
Study Arms (1)
Persistent AF
EXPERIMENTALTreatment arm to be compared with historical control.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kirk S. Honour
EndoPhotonix, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 13, 2008
Study Start
December 1, 2008
Primary Completion
January 1, 2012
Study Completion
June 1, 2012
Last Updated
August 13, 2008
Record last verified: 2008-08