RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD and standard of care TTE to screen for right to left shunt (RLS) or patent foramen ovale (PFO). Additionally, up to 150 evaluable subjects will be evaluated with NB-IS TCD and standard of care TEE.
• Subject 18 years of age and older.
• Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or transient ischemic attack (TIA) in the differential diagnosis.
• Scheduled for a transthoracic echocardiograph (TTE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent.
• Subject is able to successfully perform a Valsalva Maneuver (VM).
• Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.
• Subject 18 years of age and older.
• Subject presents with a clinical condition characterized by neurological signs and symptoms that, in the opinion of the investigator, include embolic stroke or TIA in the differential diagnosis.
• Scheduled for a transesophageal echocardiograph (TEE) study with agitated saline contrast (bubble study) per standard of care within ±30 days of informed consent.
• Subject is able to successfully perform a Valsalva Maneuver (VM).
• Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.