Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study.

Ki vehet részt

• 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)

Ki nem vehet részt

• Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVR)
• Known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year
• Planned to undergo any cardiac surgical procedure in the following 12 months
• The index procedure results in an unsuccessful TAVR, defined as procedural major adverse events (death, disabling stroke, or life-threatening or disabling bleeding), need for a second prosthesis implant, or conversion to emergent surgery
• Left ventricular ejection fraction (LVEF) <35%
• Presenting with cardiogenic shock at the time of the index procedure