LAAOS 4

The Fourth Left Atrial Appendage Occlusion Study

Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.

The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).

Enrolment Criteria

Inclusion
- a) Persistent or permanent AF
  OR
  b) Paroxysmal AF in participants with a history of ischemic stroke or systemic embolism
- Increased risk of stroke, defined as a CHA2DS2-VASc score of ≥ 4
- Treatment with OAC for at least 90 days prior to enrollment, AND no documented plan to permanently discontinue treatment with OAC for the expected duration of the trial
Exclusion
- Age < 18 years
- Current left atrial appendage (LAA) thrombus
- Prior LAA occlusion or removal (surgical or percutaneous)
- Prior percutaneous atrial septal defect or patent foramen ovale closure*
- Prior AF ablation unless evidence of recurrent qualifying AF present at least 30 days following ablation
- Planned AF ablation within 90 days of enrollment
- Individuals being treated with direct thrombin inhibitors
- Participants of childbearing potential unless they agree to employ effective birth control methods throughout the study
- Anticipated life-expectancy of < 2 years
- Individual unable or unwilling to give informed consent
*Participants with a mechanical heart valve, mitral stenosis, atrial septal defect, or a patent foramen ovale are not excluded.