Right to Left Cardiac Shunt Detection
Launched by CARDIOX CORPORATION · Jan 18, 2013
Trial Information
Current as of July 01, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • At least 18 years of age;
- • Is currently scheduled (within five days of FDS) for a TEE study with agitated saline contrast (bubble study) or has had a TEE procedure with agitated saline contrast study (bubble study) within the previous 12 months;
- • If the Subject has undergone a shunt closure procedure, the protocol related TEE must be conducted greater than 12 months post closure.
- • Is able to read and understand the ICF and has voluntarily provided written informed consent;
- • Subject is able to perform a successful Valsalva maneuver (obtaining a score of 3 stars) using the Cardiox FDS device.
- Exclusion Criteria:
- • Subjects with known allergy or sensitivity to ICG or to iodide contrast dye or iodides including medications with high iodine content;
- • Pregnant women or nursing mothers;
- • Subjects scheduled for a radioactive iodine uptake studies (eg, thyroid studies) within one week of completing this study.
About Cardiox Corporation
Cardiox Corporation is a pioneering biopharmaceutical company dedicated to advancing cardiovascular health through innovative therapies and medical technologies. Focused on developing solutions for heart-related conditions, Cardiox leverages cutting-edge research and development to address unmet medical needs in the cardiovascular space. With a commitment to enhancing patient outcomes, the company engages in rigorous clinical trials to evaluate the safety and efficacy of its products, collaborating with leading healthcare professionals and institutions to bring transformative therapies to market. Cardiox Corporation is at the forefront of cardiovascular innovation, striving to improve lives through science and compassion.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Seattle, Washington, United States
Phoenix, Arizona, United States
Houston, Texas, United States
Patients applied
Trial Officials
Michael W Jopling, MD
Study Director
Cardiox Corporation
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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