Methods:

In accordance with the Academic Research Consortium (ARC) mission statement, the authors convened diverse stakeholders, including physician and scientific leaders in interventional and structural cardiology, electrophysiology, cardiac surgery, neurology, neuroradiology, neuropsychology, clinical trialists representing academic research organizations from the United States and Europe, and representatives from the US Food and Drug Administration and the medical device industry. In-person meetings were held initially. Following the initial meeting, writing groups were established to capture the consensus on specific topics. The resulting draft was presented to and refined by the entire group at the second meeting, and the final document was subsequently adopted by general agreement.