SOLAR & ATRILAZE Atrial Fibrillation Trial (SAAF-T)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by EndoPhotonix, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
EndoPhotonix, Inc.
ClinicalTrials.gov Identifier:
NCT00734058
First received: August 11, 2008
Last updated: August 12, 2008
Last verified: August 2008
  Purpose

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
Atrial Fibrillation
Device: Laser MAZE by Ablation of Cardiac Tissue
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by EndoPhotonix, Inc.:

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 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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
Experimental: Persistent AF
Treatment arm to be compared with historical control.
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.
Other Names:
  • Maze
  • Maze procedure

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734058

Contacts
Contact: Kirk S. Honour 651-452-3000 khonour@endophotonix.com
Contact: Cory H. White cwhite@endophotonix.com

Sponsors and Collaborators
EndoPhotonix, Inc.
Investigators
Study Chair: Kirk S. Honour EndoPhotonix, Inc.
  More Information

No publications provided

Responsible Party: Kirk S Honour, Sr. Vice President, EndoPhotonix, Inc.
ClinicalTrials.gov Identifier: NCT00734058     History of Changes
Other Study ID Numbers: EP-AF-080808
Study First Received: August 11, 2008
Last Updated: August 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by EndoPhotonix, Inc.:
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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014