thromboembolic ischemic stroke and systemic embolism.
Conditions
Interventions
No concomitant procedures are to be performed at the time of the WATCHMAN
implant procedure. This includes, but is not limited to, cardiac ablation
procedures, transcutaneous valve procedures, cardi
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The subject is of legal age to participate in the study per the laws of their respective geography. 2. The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease). 3. The subject has a calculated CHA2DS2-VASc score of 2 or greater. 4. The subject is deemed by two study physicians to be unsuitable for oral anticoagulation. 5. The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel* therapy following WATCHMAN Closure Device implant. 6. The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial. 7. The subject is able and willing to return for required follow-up visits and examinations.
Exclusion criteria
Exclusion criteria: 1. The subject is unable or unwilling to return for required follow-up visits and examinations. 2. The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation). 3. The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery). 4. The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization. 5. The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event. 6. The subject has a history of atrial septal repair or has an ASD/PFO device. 7. The subject has an implanted mechanical valve prosthesis in any position. 8. The subject suffers from New York Heart Association Class IV Congestive Heart Failure. 9. The subject has LVEF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, percutaneous retrieval of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are excluded from this endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The time to first occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism 2. The time to first occurrence of major bleeding (defined as a BARC type 3 or 5 event) 3. The time to first occurrence of non-procedure related major bleeding (defined as a BARC type 3 or 5 event) 4. Non-disabling vs. disabling and fatal stroke analysis as defined using VARC-2 5. The time to occurrence of cardiovascular death (cardiovascular and/or unexplained cause) 6. The time to occurrence of all-cause death 7. The time to first occurrence of all-cause stroke (ischemic and/or hemorrhagic) 8. The time to first occurrence of hemorrhagic stroke 9. Procedural success defined as a completed WATCHMAN implant procedure with no primary safety endpoint and no device embolization. 10. Rates of effective (defined as jet size of | — |
Countries
Netherlands
Outcome results
None listed