Research Study: OPTION
Condition:
atrial fibrillation
Study Sponsor: Boston Scientific
Study Investigator: Mario Goessl, MD
Study Contact: Christine Majeski
christine.majeski@allina.com
612-863-3546
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
Eligibility Criteria:

  • The subject is of legal age to participate in the study per the laws of their respective geography.
  • Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180 days prior to randomization (sequential) or is planning to have clinically indicated catheter ablation within 10 days of randomization (concomitant).
  • The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
  • The subject is deemed to be suitable for the defined protocol pharmacologic regimen.
  • The subject is able to undergo TEE examinations.
  • The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.
  • The subject is able and willing to return for required follow-up visits and examinations.

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!

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