WATCHMAN Implantation During Hybrid Ablation "WINNING"


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation,
- Eligible at least for short-term OAC therapy,
- No other conditions that would require long-term OAC therapy, suggested by current standard medical practice, and thus is eligible to stop OAC if the LAA is sealed,
- Calculated CHA2DS2-VASc score of 1 or more,
- 18 years of age or older, able and willing to provide written informed consent.

Exclusion Criteria

- Current New York Heart Association Class IV Congestive Heart Failure,
- Current thrombocytopenia (< 100x10E9/L) or anemia (hemoglobin <6.2 mmol/L),
- Active infection or sepsis,
- Resting heart rate > 110 beats per minute,
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days,
- Recent myocardial infarction (within 3 months),
- Transient case of AF (i.e., secondary to recent cardiac surgery (within 3 months)),
- Planned cardioversion 30 days post implant of the WATCHMAN Device,
- Implanted mechanical valve prosthesis,
- History of obliterated LAA,
- History of heart transplantation,
- Symptomatic carotid disease (i.e., carotid stenosis >50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months),
- Necessity to use long-term OAC,
- Contraindication for use of OAC or dual anti-platelet therapy,
- Contraindication for use of aspirin,
- Pregnancy or planned pregnancy during the course of the investigation,
- Life expectancy less than 2 years,
- Participation in any other clinical study involving an investigational drug or device.
Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:
- Left ventricular ejection fraction (LVEF) < 30%,
- Intracardiac thrombus as visualized by TEE within 2 days prior to implant,
- High risk patent foramen ovale,
- Current atrial septal defect and/or previous atrial septal repair or closure device,
- Significant mitral valve stenosis (i.e., MV 4. 5 cm2),
- Existing pericardial effusion of >3 mm,
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch,
- Cardiac tumor.