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SOLAR & ATRILAZE Atrial Fibrillation Trial (SAAF-T)

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Laser MAZE by Ablation of Cardiac Tissue
Sponsored by
EndoPhotonix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Persistent AF

    Arm Description

    Treatment arm to be compared with historical control.

    Outcomes

    Primary Outcome Measures

    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
    Acute SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage

    Secondary Outcome Measures

    SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
    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.

    Full Information

    First Posted
    August 11, 2008
    Last Updated
    August 12, 2008
    Sponsor
    EndoPhotonix, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00734058
    Brief Title
    SOLAR & ATRILAZE Atrial Fibrillation Trial
    Acronym
    SAAF-T
    Official Title
    Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    January 2012 (Anticipated)
    Study Completion Date
    June 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    EndoPhotonix, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Persistent AF
    Arm Type
    Experimental
    Arm Description
    Treatment arm to be compared with historical control.
    Intervention Type
    Device
    Intervention Name(s)
    Laser MAZE by Ablation of Cardiac Tissue
    Other Intervention Name(s)
    Maze, Maze procedure
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Time Frame
    180 days
    Title
    Acute SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
    Time Frame
    0 through 30 days or length of stay
    Secondary Outcome Measure Information:
    Title
    SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage
    Time Frame
    180 days
    Title
    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.
    Time Frame
    180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kirk S. Honour
    Phone
    651-452-3000
    Email
    khonour@endophotonix.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cory H. White
    Email
    cwhite@endophotonix.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kirk S. Honour
    Organizational Affiliation
    EndoPhotonix, Inc.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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