Hi Joe,
I think this study is for new patients, as the eligibility requirements include, Clinically indicated for TAVR (See the Criteria below)
I think the used of " indicated " means in need of.
Eligibility Criteria
AGES ELIGIBLE FOR STUDY
18 Years and older
STUDY POPULATION
A minimum of 50 and up to 100 adults presenting with symptomatic severe aortic stenosis referred for clinically indicated TAVR at Yale New Haven Hospital who meet all eligibility criteria.
Inclusion Criteria:Male or non-pregnant female ≥18 years of age
Clinically indicated for TAVR
Aortic annular size measures 21-25 mm diameter based on pre-procedure Computed Tomography Angiography (CTA)
Able to exercise and, in the judgment of the investigator, is likely to be physically able to comply with the protocol requirements regarding exercise echocardiography
Willing to comply with protocol-specified follow-up evaluations
The participant or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Just my thoughts, I've been wrong before
We must catch up again soon!
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