SOLAR & ATRILAZE Atrial Fibrillation Trial

Atrial Fibrillation Clinical Trial

— SAAF-T  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00734058
• Other study ID #: EP-AF-080808
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 11, 2008
• Last updated: August 12, 2008
• Start date: December 2008
• Est. completion date: June 2012

Study information

• Verified date: August 2008
• Source: EndoPhotonix, Inc.
• Contact: Kirk S. Honour
• Phone: 651-452-3000
• Email: khonour[@]endophotonix.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EndoPhotonix, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No