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Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial (ECHOCATH Trial)
Status: Recruiting
This study investigates the optimization of how blood flows through heart valve replacements after a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure. It compares two methods used to measure valve performance: heart ultrasound and catheter-based pressure measurements. Patients are randomly assigned to have their treatment guided by one of these methods. Researchers will evaluate which approach leads to better valve function, quality of life, and safety outcomes.
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
Surgical aortic bioprosthetic valve failure with severe aortic stenosis/regurgitation
Approved for valve-in-valve procedure by Heart Team
Surgical stented bioprosthetic valve (size ?25 mm)
Transcatheter aortic valve replacement with SAPIEN 3 Ultra valve
Exclusion Criteria:
Stentless or sutureless surgical valves
Trifecta or Hancock II bioprosthesis
Significant chance that the heart procedure could block one of the arteries that supplies blood to the heart muscle.
Unable to provide consentInterventions:
Drug/Device: TAVR
Conditions:
Aortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis Failure
Keywords:
Surgical aortic bioprosthetic valve dysfunction, Valve in Valve TAVR
Contact(s): Darla Washington - dawashi19@hfhs.org
Principal Investigator: Pedro Villablanca
Principal Investigator ID: pvillab1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov