SOLAR & ATRILAZE Atrial Fibrillation Trial (SAAF-T)

EndoPhotonix

Status and phase

Unknown

Phase 3

Conditions

Atrial Fibrillation

Treatments

Device: Laser MAZE by Ablation of Cardiac Tissue

Study type

Interventional

Funder types

Industry

Identifiers

NCT00734058

EP-AF-080808

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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