Atrial fibrillation
Conditions
Interventions
The intervention consists of the WATCHMAN Device implantation.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The patient: * Has documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation, * Is eligible at least for short-term OAC therapy, * Has 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, * Has a calculated CHA2DS2-VASc score of 1 or more, * Is 18 years of age or older, able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: * Current New York Heart Association Class IV Congestive Heart Failure, * Current thrombocytopenia ( 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) 3 mm, * Complex atheroma with mobile plaque of the descending aorta and/or aortic arch, * Cardiac tumor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint for this study comprises major complications and includes: * Acute death (7days days): * Cardiovascular or unexplained death, * Embolic or hemorrhagic TIA or CVA, * Systemic embolization. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints for this study are: * Prolonged procedure time, * Prolonged radiation exposure time and dosage, * (Serious) Adverse Device Events ((S)ADE), * (S)AEs. | — |
Countries
Netherlands
Outcome results
None listed