SOLAR & ATRILAZE Atrial Fibrillation Trial (SAAF-T)

August 12, 2008 updated by: EndoPhotonix, Inc.

Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 0 through 30 days or length of stay
0 through 30 days or length of stay

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EndoPhotonix, Inc.

Investigators

  • Study Chair: Kirk S. Honour, EndoPhotonix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

August 13, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-AF-080808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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